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    Clinical Trial Results:
    A Phase I/IIa Study Assessing Single and Multiple Doses of IDX21437 in Healthy and HCV-Infected Subjects

    Summary
    EudraCT number
    2013-004043-23
    Trial protocol
    BE  
    Global end of trial date
    11 Sep 2015

    Results information
    Results version number
    v1(current)
    This version publication date
    26 Aug 2016
    First version publication date
    26 Aug 2016
    Other versions

    Trial information

    Close Top of page
    Trial identification
    Sponsor protocol code
    3682-001
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    NCT01974687
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp.
    Sponsor organisation address
    2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
    Public contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Scientific contact
    Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    No
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    11 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    11 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This is a multi-part study to evaluate the safety, tolerability, and pharmacokinetics (PK) of MK-3682 (IDX21437) in healthy participants and in participants infected with HCV genotype (GT)1-GT6. The effect of food on the PK of MK-3682 will be evaluated. The antiviral activity of MK-3682 will also be assessed in HCV-infected participants.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statuses and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    31 Oct 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Belgium: 3
    Country: Number of subjects enrolled
    Canada: 95
    Country: Number of subjects enrolled
    Moldova, Republic of: 66
    Country: Number of subjects enrolled
    New Zealand: 14
    Worldwide total number of subjects
    178
    EEA total number of subjects
    3
    Number of subjects enrolled per age group
    In utero
    0
    Preterm newborn - gestational age < 37 wk
    0
    Newborns (0-27 days)
    0
    Infants and toddlers (28 days-23 months)
    0
    Children (2-11 years)
    0
    Adolescents (12-17 years)
    0
    Adults (18-64 years)
    177
    From 65 to 84 years
    1
    85 years and over
    0

    Subject disposition

    Close Top of page
    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    This study enrolled healthy, adult participants (Group A), adult participants with chronic hepatitis C infection without cirrhosis (Groups B, C, D and F), and HCV-infected participants with mild hepatic impairment (Group E). Additional inclusion and exclusion criteria applied.

    Period 1
    Period 1 title
    Overall Period
    Is this the baseline period?
    Yes
    Allocation method
    Randomised - controlled
    Blinding used
    Double blind
    Roles blinded
    Subject, Investigator

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) (capsule)
    Arm description
    Participants were administered a single dose of MK-3682-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of MK-3682-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).
    Arm type
    Placebo

    Investigational medicinal product name
    MK-3682-matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682-matching placebo oral capsule x 1 day

    Arm title
    Group A - MK-3682 10 mg (Cohort 1a) (capsule)
    Arm description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 10 mg oral capsule x 1 day

    Arm title
    Group A - MK-3682 25 mg (Cohort 2a) (capsule)
    Arm description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 25 mg oral capsule x 1 day

    Arm title
    Group A - MK-3682 50 mg (Cohort 3a) (capsule)
    Arm description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 50 mg oral capsule x 1 day

    Arm title
    Group A - MK-3682 150 mg (Cohort 4a) (capsule)
    Arm description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 150 mg oral capsule x 1 day

    Arm title
    Group A - MK-3682 300 mg (Cohort 5a) (capsule)
    Arm description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg oral capsule x 1 day

    Arm title
    Group A - Placebo (Cohort 6a)
    Arm description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules for 7 days under fasted conditions.
    Arm type
    Placebo

    Investigational medicinal product name
    MK-3682-matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682-matching placebo oral capsule once daily (QD) x 7 days

    Arm title
    Group A - MK-3682 300 mg (Cohort 6a)
    Arm description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg QD x 7 days

    Arm title
    Group B - MK-3682 10 mg (Cohort 1b)
    Arm description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 10 mg oral capsule x 1 day

    Arm title
    Group B - MK-3682 25 mg (Cohort 2b)
    Arm description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 25 mg oral capsule x 1 day

    Arm title
    Group B - MK-3682 50 mg (Cohort 3b)
    Arm description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 50 mg oral capsule x 1 day

    Arm title
    Group B - MK-3682 150 mg (Cohort 4b)
    Arm description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 150 mg oral capsule x 1 day

    Arm title
    Group B - MK-3682 300 mg (Cohort 5b)
    Arm description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg oral capsule x 1 day

    Arm title
    Groups C and D - MK-3682 50 mg (capsule)
    Arm description
    Participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 50 mg oral capsule QD x 7 days

    Arm title
    Groups C and D - MK-3682 150 mg (capsule)
    Arm description
    Participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 150 mg oral capsule QD x 7 days

    Arm title
    Group C - MK-3682 250 mg (capsule)
    Arm description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 250 mg oral capsule QD x 7 days

    Arm title
    Groups C and D - MK-3682 300 mg (capsule)
    Arm description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg oral capsule QD x 7 days

    Arm title
    Group C - MK-3682 400 mg (capsule)
    Arm description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 400 mg oral capsule QD x 7 days

    Arm title
    Group C - MK-3682 300 mg (tablet)
    Arm description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg oral tablet QD x 7 days

    Arm title
    Group C - MK-3682 450 mg (tablet)
    Arm description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 450 mg oral tablet QD x 7 days

    Arm title
    Groups C and D - Placebo (pooled) (capsule)
    Arm description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Placebo

    Investigational medicinal product name
    MK-3682-matching placebo
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule, Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682-matching placebo oral capsule or oral tablet QD x 7 days

    Arm title
    Group E - MK-3682 150 mg (Cohort 1e) (capsule)
    Arm description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 150 mg oral capsule x 1 day

    Arm title
    Group E - MK-3682 300 mg (Cohort 2e) (capsule)
    Arm description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg oral capsule QD x 7 days

    Arm title
    Group E - MK-3682 450 mg (Cohort 3e) (tablet)
    Arm description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 450 mg oral tablet QD x 7 days

    Arm title
    Group F - MK-3682 300 mg (tablet)
    Arm description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered Itraconazole 200 mg as oral solution twice daily on Day -5 and 200 mg once daily from Day -4 to Day 11.
    Arm type
    Experimental

    Investigational medicinal product name
    MK-3682
    Investigational medicinal product code
    Other name
    IDX21437
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    MK-3682 300 mg oral tablet QD x 7 days

    Investigational medicinal product name
    itraconazole 200 mg
    Investigational medicinal product code
    Other name
    Sporanox®
    Pharmaceutical forms
    Oral solution
    Routes of administration
    Oral use
    Dosage and administration details
    itraconazole 200 mg taken as either a 10 mg/mL oral solution or as 100 mg oral capsules QD x 11 days

    Number of subjects in period 1
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) (capsule) Group A - MK-3682 10 mg (Cohort 1a) (capsule) Group A - MK-3682 25 mg (Cohort 2a) (capsule) Group A - MK-3682 50 mg (Cohort 3a) (capsule) Group A - MK-3682 150 mg (Cohort 4a) (capsule) Group A - MK-3682 300 mg (Cohort 5a) (capsule) Group A - Placebo (Cohort 6a) Group A - MK-3682 300 mg (Cohort 6a) Group B - MK-3682 10 mg (Cohort 1b) Group B - MK-3682 25 mg (Cohort 2b) Group B - MK-3682 50 mg (Cohort 3b) Group B - MK-3682 150 mg (Cohort 4b) Group B - MK-3682 300 mg (Cohort 5b) Groups C and D - MK-3682 50 mg (capsule) Groups C and D - MK-3682 150 mg (capsule) Group C - MK-3682 250 mg (capsule) Groups C and D - MK-3682 300 mg (capsule) Group C - MK-3682 400 mg (capsule) Group C - MK-3682 300 mg (tablet) Group C - MK-3682 450 mg (tablet) Groups C and D - Placebo (pooled) (capsule) Group E - MK-3682 150 mg (Cohort 1e) (capsule) Group E - MK-3682 300 mg (Cohort 2e) (capsule) Group E - MK-3682 450 mg (Cohort 3e) (tablet) Group F - MK-3682 300 mg (tablet)
    Started
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    13
    13
    10
    19
    9
    9
    11
    9
    3
    3
    8
    8
    Treated
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    11
    10
    8
    18
    8
    8
    8
    9
    3
    3
    8
    8
    Completed
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    11
    10
    8
    18
    8
    8
    8
    9
    3
    3
    8
    8
    Not completed
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    2
    3
    2
    1
    1
    1
    3
    0
    0
    0
    0
    0
         Did Not Receive Treatment
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    -
    2
    3
    2
    1
    1
    1
    3
    -
    -
    -
    -
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of MK-3682-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).

    Reporting group title
    Group A - MK-3682 10 mg (Cohort 1a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 25 mg (Cohort 2a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 50 mg (Cohort 3a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 150 mg (Cohort 4a) (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.

    Reporting group title
    Group A - MK-3682 300 mg (Cohort 5a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - Placebo (Cohort 6a)
    Reporting group description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules for 7 days under fasted conditions.

    Reporting group title
    Group A - MK-3682 300 mg (Cohort 6a)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group B - MK-3682 10 mg (Cohort 1b)
    Reporting group description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 25 mg (Cohort 2b)
    Reporting group description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 50 mg (Cohort 3b)
    Reporting group description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 150 mg (Cohort 4b)
    Reporting group description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 300 mg (Cohort 5b)
    Reporting group description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 50 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 150 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 250 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 300 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 400 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 300 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 450 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - Placebo (pooled) (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group E - MK-3682 150 mg (Cohort 1e) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Reporting group title
    Group E - MK-3682 300 mg (Cohort 2e) (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group E - MK-3682 450 mg (Cohort 3e) (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Group F - MK-3682 300 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered Itraconazole 200 mg as oral solution twice daily on Day -5 and 200 mg once daily from Day -4 to Day 11.

    Reporting group values
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) (capsule) Group A - MK-3682 10 mg (Cohort 1a) (capsule) Group A - MK-3682 25 mg (Cohort 2a) (capsule) Group A - MK-3682 50 mg (Cohort 3a) (capsule) Group A - MK-3682 150 mg (Cohort 4a) (capsule) Group A - MK-3682 300 mg (Cohort 5a) (capsule) Group A - Placebo (Cohort 6a) Group A - MK-3682 300 mg (Cohort 6a) Group B - MK-3682 10 mg (Cohort 1b) Group B - MK-3682 25 mg (Cohort 2b) Group B - MK-3682 50 mg (Cohort 3b) Group B - MK-3682 150 mg (Cohort 4b) Group B - MK-3682 300 mg (Cohort 5b) Groups C and D - MK-3682 50 mg (capsule) Groups C and D - MK-3682 150 mg (capsule) Group C - MK-3682 250 mg (capsule) Groups C and D - MK-3682 300 mg (capsule) Group C - MK-3682 400 mg (capsule) Group C - MK-3682 300 mg (tablet) Group C - MK-3682 450 mg (tablet) Groups C and D - Placebo (pooled) (capsule) Group E - MK-3682 150 mg (Cohort 1e) (capsule) Group E - MK-3682 300 mg (Cohort 2e) (capsule) Group E - MK-3682 450 mg (Cohort 3e) (tablet) Group F - MK-3682 300 mg (tablet) Total
    Number of subjects
    10 6 6 6 6 6 2 6 3 3 3 3 3 13 13 10 19 9 9 11 9 3 3 8 8 178
    Age Categorical
    Units: Subjects
        In utero
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Preterm newborn infants (gestational age < 37 wks)
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Newborns (0-27 days)
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Infants and toddlers (28 days-23 months)
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Children (2-11 years)
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adolescents (12-17 years)
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
        Adults (18-64 years)
    10 6 6 6 6 6 2 6 3 3 3 3 3 13 13 9 19 9 9 11 9 3 3 8 8 177
        From 65-84 years
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 1 0 0 0 0 0 0 0 0 0 1
        85 years and over
    0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0 0
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    35.3 ± 7.7 29.2 ± 7.4 33.3 ± 15.1 31.3 ± 11.6 35.5 ± 11.8 35.2 ± 9.9 36 ± 2.8 35.3 ± 12.7 37 ± 9.5 42.3 ± 7.2 46.7 ± 4.2 43.3 ± 5.7 41.3 ± 9 42 ± 10 43.3 ± 9.6 44.4 ± 12.1 40.1 ± 11.4 44 ± 8.2 41.3 ± 11.2 44.6 ± 10.5 43.7 ± 7.7 57 ± 4.4 56.3 ± 3.1 49.1 ± 8 43.1 ± 12.5 -
    Gender Categorical
    Units: Subjects
        Female
    4 4 2 3 5 4 0 4 0 0 1 2 1 6 0 5 5 3 5 5 3 0 0 1 6 69
        Male
    6 2 4 3 1 2 2 2 3 3 2 1 2 7 13 5 14 6 4 6 6 3 3 7 2 109

    End points

    Close Top of page
    End points reporting groups
    Reporting group title
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of MK-3682-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).

    Reporting group title
    Group A - MK-3682 10 mg (Cohort 1a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 25 mg (Cohort 2a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 50 mg (Cohort 3a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 150 mg (Cohort 4a) (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.

    Reporting group title
    Group A - MK-3682 300 mg (Cohort 5a) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - Placebo (Cohort 6a)
    Reporting group description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules for 7 days under fasted conditions.

    Reporting group title
    Group A - MK-3682 300 mg (Cohort 6a)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group B - MK-3682 10 mg (Cohort 1b)
    Reporting group description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 25 mg (Cohort 2b)
    Reporting group description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 50 mg (Cohort 3b)
    Reporting group description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 150 mg (Cohort 4b)
    Reporting group description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 300 mg (Cohort 5b)
    Reporting group description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 50 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 150 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 250 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 300 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 400 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 300 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 450 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - Placebo (pooled) (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group E - MK-3682 150 mg (Cohort 1e) (capsule)
    Reporting group description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Reporting group title
    Group E - MK-3682 300 mg (Cohort 2e) (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group E - MK-3682 450 mg (Cohort 3e) (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Group F - MK-3682 300 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered Itraconazole 200 mg as oral solution twice daily on Day -5 and 200 mg once daily from Day -4 to Day 11.

    Subject analysis set title
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of MK-3682-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).

    Subject analysis set title
    Group A - MK-3682 10 mg (Cohort 1a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 25 mg (Cohort 2a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 50 mg (Cohort 3a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 150 mg (Cohort 4a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.

    Subject analysis set title
    Group A - MK-3682 300 mg (Cohort 5a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - Placebo (Cohort 6a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682-matching placebo oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 300 mg (Cohort 6a) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 10 mg (Cohort 1b) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 25 mg (Cohort 2b) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 50 mg (Cohort 3b) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 50 mg oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 150 mg (Cohort 4b) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 300 mg (Cohort 5b) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 300 mg oral capsules under fasted conditions.

    Subject analysis set title
    Groups C and D - Placebo (pooled) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants administered single doses of MK-3682-matching placebo as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 50 mg (capsule) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 150 mg (capsule) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 250 mg (capsule) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 300 mg (capsule) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 400 mg (capsule) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 300 mg (tablet) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 450 mg (tablet) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 150 mg (Cohort 1e) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 300 mg (Cohort 2e) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 450 mg (Cohort 3e) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group F - MK-3682 300 mg (tablet) - AST
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered Itraconazole 200 mg twice daily as oral solution on Day -5 and 200 mg once daily from Day -4 to Day 11.

    Subject analysis set title
    Group A - MK-3682 10 mg (Cohort 1a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 25 mg (Cohort 2a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 50 mg (Cohort 3a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 150 mg (Cohort 4a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.

    Subject analysis set title
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.

    Subject analysis set title
    Group A - MK-3682 300 mg (Cohort 5a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 10 mg (Cohort 1b) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 25 mg (Cohort 2b) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 50 mg (Cohort 3b) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 150 mg (Cohort 4b) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group B - MK-3682 300 mg (Cohort 5b) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 50 mg (capsule) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Group C and D participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 150 mg (capsule) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Group C and D participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 250 mg (capsule) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 300 mg (capsule) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Group C and D participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 400 mg (capsule) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 300 mg (tablet) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 450 mg (tablet) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 300 mg (Cohort 2e) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 450 mg (Cohort 3e) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group F - MK-3682 300 mg (tablet) - PK
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered Itraconazole 200 mg twice daily as oral solution on day -5 and 200 mg once daily from day -4 to Day 11.

    Subject analysis set title
    Group B - MK-3682 300 mg (Cohort 4b) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Groups C and D - Placebo (pooled) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants administered single doses of MK-3682-matching placebo as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 50 mg (capsule) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 150 mg (capsule) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 250 mg (capsule) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Groups C and D - MK-3682 300 mg (capsule) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 400 mg (capsule) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 300 mg (capsule) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 300 mg (tablet) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group C - MK-3682 450 mg (tablet) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 150 mg (Cohort 1e) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 300 mg (Cohort 2e) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Subject analysis set title
    Group E - MK-3682 450 mg (Cohort 3e) - PP
    Subject analysis set type
    Per protocol
    Subject analysis set description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Primary: Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (AE)

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    End point title
    Percentage of Participants Who Experienced at Least One Treatment-Emergent Adverse Event (AE) [1]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product that does not necessarily have a causal relationship with the study drug(s). An AE can therefore be any unfavorable and unintended sign (including an abnormal lab finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drugs(s). All Participants as Treated (APaT) Population: all participants who received at least one dose of the study drug. For Cohort 4a, only participants on the fasted regimen are included.
    End point type
    Primary
    End point timeframe
    Up to 42 days
    Notes
    [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) - AST Group A - MK-3682 10 mg (Cohort 1a) - AST Group A - MK-3682 25 mg (Cohort 2a) - AST Group A - MK-3682 50 mg (Cohort 3a) - AST Group A - MK-3682 150 mg (Cohort 4a) - AST Group A - MK-3682 300 mg (Cohort 5a) - AST Group A - Placebo (Cohort 6a) - AST Group A - MK-3682 300 mg (Cohort 6a) - AST Group B - MK-3682 10 mg (Cohort 1b) - AST Group B - MK-3682 25 mg (Cohort 2b) - AST Group B - MK-3682 50 mg (Cohort 3b) - AST Group B - MK-3682 150 mg (Cohort 4b) - AST Group B - MK-3682 300 mg (Cohort 5b) - AST Groups C and D - Placebo (pooled) - AST Groups C and D - MK-3682 50 mg (capsule) - AST Groups C and D - MK-3682 150 mg (capsule) - AST Group C - MK-3682 250 mg (capsule) - AST Groups C and D - MK-3682 300 mg (capsule) - AST Group C - MK-3682 400 mg (capsule) - AST Group C - MK-3682 300 mg (tablet) - AST Group C - MK-3682 450 mg (tablet) - AST Group E - MK-3682 150 mg (Cohort 1e) - AST Group E - MK-3682 300 mg (Cohort 2e) - AST Group E - MK-3682 450 mg (Cohort 3e) - AST Group F - MK-3682 300 mg (tablet) - AST
    Number of subjects analysed
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    9
    11
    10
    8
    18
    8
    8
    8
    3
    3
    8
    8
    Units: Participants
        number (not applicable)
    50
    0
    33.3
    33.3
    66.7
    50
    50
    33.3
    33.3
    66.7
    33.3
    66.7
    66.7
    66.7
    72.7
    70
    87.5
    44.4
    62.5
    75
    62.5
    0
    100
    62.5
    37.5
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event (SAE)

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    End point title
    Percentage of Participants Who Experienced at Least One Serious Treatment-Emergent Adverse Event (SAE) [2]
    End point description
    An SAE is defined as any untoward medical occurrence that at any dose: Results in death - this includes deaths that appear to be completely unrelated to study drug (e.g., car accident); Is life-threatening - a life-threatening AE is any AE that places the participant, in the view of the investigator, at immediate risk of death from the reaction as it occurred; Requires inpatient hospitalization or prolongation of existing hospitalization; Results in persistent or significant disability/incapacity; Is a congenital anomaly/birth defect; Is an important medical event. APaT Population: all participants who received at least one dose of the study drug. For Cohort 4a, only participants on the fasted regimen are included.
    End point type
    Primary
    End point timeframe
    Up to 42 days
    Notes
    [2] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) - AST Group A - MK-3682 10 mg (Cohort 1a) - AST Group A - MK-3682 25 mg (Cohort 2a) - AST Group A - MK-3682 50 mg (Cohort 3a) - AST Group A - MK-3682 150 mg (Cohort 4a) - AST Group A - MK-3682 300 mg (Cohort 5a) - AST Group A - Placebo (Cohort 6a) - AST Group A - MK-3682 300 mg (Cohort 6a) - AST Group B - MK-3682 10 mg (Cohort 1b) - AST Group B - MK-3682 25 mg (Cohort 2b) - AST Group B - MK-3682 50 mg (Cohort 3b) - AST Group B - MK-3682 150 mg (Cohort 4b) - AST Group B - MK-3682 300 mg (Cohort 5b) - AST Groups C and D - Placebo (pooled) - AST Groups C and D - MK-3682 50 mg (capsule) - AST Groups C and D - MK-3682 150 mg (capsule) - AST Group C - MK-3682 250 mg (capsule) - AST Groups C and D - MK-3682 300 mg (capsule) - AST Group C - MK-3682 400 mg (capsule) - AST Group C - MK-3682 300 mg (tablet) - AST Group C - MK-3682 450 mg (tablet) - AST Group E - MK-3682 150 mg (Cohort 1e) - AST Group E - MK-3682 300 mg (Cohort 2e) - AST Group E - MK-3682 450 mg (Cohort 3e) - AST Group F - MK-3682 300 mg (tablet) - AST
    Number of subjects analysed
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    9
    11
    10
    8
    18
    8
    8
    8
    3
    3
    8
    8
    Units: Participants
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced Treatment-Emergent Dose-Limiting Toxicity (DLT)

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    End point title
    Percentage of Participants Who Experienced Treatment-Emergent Dose-Limiting Toxicity (DLT) [3]
    End point description
    A DLT is defined as the occurrence of any of the following events after administration of the study drug: any SAE considered by the investigator to be at least reasonably or possibly related to the study drug; any ≥ Grade 3 clinical AE considered by the investigator to be at least reasonably or possibly related to the study drug; any ≥ Grade 3 confirmed lab abnormalities considered by the investigator to be at least reasonably or possibly related to the study drug (except for asymptomatic Grade 3/4 cholesterol and triglyceride); any clinical or lab AE of any intensity that is considered by the investigator to be at least reasonably or possibly related to study drug that necessitates permanent discontinuation of study drug; and confirmed increase in QTcF≥60 ms over Baseline or absolute QTcF≥500 ms. APaT Population: all participants who received at least one dose of the study drug. For Cohort 4a, only participants on the fasted regimen are included.
    End point type
    Primary
    End point timeframe
    Up to 13 days
    Notes
    [3] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) - AST Group A - MK-3682 10 mg (Cohort 1a) - AST Group A - MK-3682 25 mg (Cohort 2a) - AST Group A - MK-3682 50 mg (Cohort 3a) - AST Group A - MK-3682 150 mg (Cohort 4a) - AST Group A - MK-3682 300 mg (Cohort 5a) - AST Group A - Placebo (Cohort 6a) - AST Group A - MK-3682 300 mg (Cohort 6a) - AST Group B - MK-3682 10 mg (Cohort 1b) - AST Group B - MK-3682 25 mg (Cohort 2b) - AST Group B - MK-3682 50 mg (Cohort 3b) - AST Group B - MK-3682 150 mg (Cohort 4b) - AST Group B - MK-3682 300 mg (Cohort 5b) - AST Groups C and D - Placebo (pooled) - AST Groups C and D - MK-3682 50 mg (capsule) - AST Groups C and D - MK-3682 150 mg (capsule) - AST Group C - MK-3682 250 mg (capsule) - AST Groups C and D - MK-3682 300 mg (capsule) - AST Group C - MK-3682 400 mg (capsule) - AST Group C - MK-3682 300 mg (tablet) - AST Group C - MK-3682 450 mg (tablet) - AST Group E - MK-3682 150 mg (Cohort 1e) - AST Group E - MK-3682 300 mg (Cohort 2e) - AST Group E - MK-3682 450 mg (Cohort 3e) - AST Group F - MK-3682 300 mg (tablet) - AST
    Number of subjects analysed
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    9
    11
    10
    8
    18
    8
    8
    8
    3
    3
    8
    8
    Units: Participants
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    9.1
    10
    0
    5.6
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants Who Experienced at Least One Grade 1, 2, 3, 4 or 5 Laboratory Abnormality

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    End point title
    Percentage of Participants Who Experienced at Least One Grade 1, 2, 3, 4 or 5 Laboratory Abnormality [4]
    End point description
    Laboratory abnormalities were graded using the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events. Grade 1: Mild TEAE as Worst Severity; Grade 2: Moderate TEAE as Worst Severity; Grade 3: Severe TEAE as Worst Severity; Grade 4: Potentially Life-Threatening TEAE as Worst Severity; Grade 5: TEAE Leading to Death. APaT Population: all participants who received at least one dose of the study drug. For Cohort 4a, only participants on the fasted regimen are included.
    End point type
    Primary
    End point timeframe
    Up to 42 days
    Notes
    [4] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) - AST Group A - MK-3682 10 mg (Cohort 1a) - AST Group A - MK-3682 25 mg (Cohort 2a) - AST Group A - MK-3682 50 mg (Cohort 3a) - AST Group A - MK-3682 150 mg (Cohort 4a) - AST Group A - MK-3682 300 mg (Cohort 5a) - AST Group A - Placebo (Cohort 6a) - AST Group A - MK-3682 300 mg (Cohort 6a) - AST Group B - MK-3682 10 mg (Cohort 1b) - AST Group B - MK-3682 25 mg (Cohort 2b) - AST Group B - MK-3682 50 mg (Cohort 3b) - AST Group B - MK-3682 150 mg (Cohort 4b) - AST Group B - MK-3682 300 mg (Cohort 5b) - AST Groups C and D - Placebo (pooled) - AST Groups C and D - MK-3682 50 mg (capsule) - AST Groups C and D - MK-3682 150 mg (capsule) - AST Group C - MK-3682 250 mg (capsule) - AST Groups C and D - MK-3682 300 mg (capsule) - AST Group C - MK-3682 400 mg (capsule) - AST Group C - MK-3682 300 mg (tablet) - AST Group C - MK-3682 450 mg (tablet) - AST Group E - MK-3682 150 mg (Cohort 1e) - AST Group E - MK-3682 300 mg (Cohort 2e) - AST Group E - MK-3682 450 mg (Cohort 3e) - AST Group F - MK-3682 300 mg (tablet) - AST
    Number of subjects analysed
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    9
    11
    10
    8
    18
    8
    8
    8
    3
    3
    8
    8
    Units: Participants
    number (not applicable)
        Grade 1
    50
    0
    16.7
    16.7
    50
    33.3
    50
    33.3
    0
    66.7
    33.3
    66.7
    66.7
    33.3
    45.5
    60
    37.5
    33.3
    0
    37.5
    25
    0
    100
    12.5
    0
        Grade 2
    0
    0
    16.7
    16.7
    16.7
    16.7
    0
    0
    0
    0
    0
    0
    0
    33.3
    18.2
    0
    50
    5.6
    62.5
    37.5
    25
    0
    0
    37.5
    37.5
        Grade 3
    0
    0
    0
    0
    0
    0
    0
    0
    33.3
    0
    0
    0
    0
    0
    9.1
    10
    0
    5.6
    0
    0
    0
    0
    0
    12.5
    0
        Grade 4
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    12.5
    0
    0
    0
    0
        Grade 5
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Percentage of Participants With at Least One Treatment-Emergent AE for Which Study Treatment Was Withdrawn

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    End point title
    Percentage of Participants With at Least One Treatment-Emergent AE for Which Study Treatment Was Withdrawn [5]
    End point description
    An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product, that does not necessarily have a causal relationship with the study drug(s). An AE can therefore be any unfavorable and unintended sign (including an abnormal lab finding), symptom, or disease temporally associated with the use of study drug(s), whether or not related to study drugs(s). APaT Population: all participants who received at least one dose of the study drug. For Cohort 4a, only participants on the fasted regimen are included.
    End point type
    Primary
    End point timeframe
    Up to 13 days
    Notes
    [5] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled) - AST Group A - MK-3682 10 mg (Cohort 1a) - AST Group A - MK-3682 25 mg (Cohort 2a) - AST Group A - MK-3682 50 mg (Cohort 3a) - AST Group A - MK-3682 150 mg (Cohort 4a) - AST Group A - MK-3682 300 mg (Cohort 5a) - AST Group A - Placebo (Cohort 6a) - AST Group A - MK-3682 300 mg (Cohort 6a) - AST Group B - MK-3682 10 mg (Cohort 1b) - AST Group B - MK-3682 25 mg (Cohort 2b) - AST Group B - MK-3682 50 mg (Cohort 3b) - AST Group B - MK-3682 150 mg (Cohort 4b) - AST Group B - MK-3682 300 mg (Cohort 5b) - AST Groups C and D - Placebo (pooled) - AST Groups C and D - MK-3682 50 mg (capsule) - AST Groups C and D - MK-3682 150 mg (capsule) - AST Group C - MK-3682 250 mg (capsule) - AST Groups C and D - MK-3682 300 mg (capsule) - AST Group C - MK-3682 400 mg (capsule) - AST Group C - MK-3682 300 mg (tablet) - AST Group C - MK-3682 450 mg (tablet) - AST Group E - MK-3682 150 mg (Cohort 1e) - AST Group E - MK-3682 300 mg (Cohort 2e) - AST Group E - MK-3682 450 mg (Cohort 3e) - AST Group F - MK-3682 300 mg (tablet) - AST
    Number of subjects analysed
    10
    6
    6
    6
    6
    6
    2
    6
    3
    3
    3
    3
    3
    9
    11
    10
    8
    18
    8
    8
    8
    3
    3
    8
    8
    Units: Participants
        number (not applicable)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Primary: Area Under the Plasma Drug Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    Area Under the Plasma Drug Concentration-Time Curve from Time Zero to Last Measurable Concentration (AUC0-t) of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [6]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [6] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    0.041 ± 32.7
    0.0837 ± 27.9
    0.246 ± 63.2
    1.67 ± 62.7
    2.78 ± 37.7
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a)

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    End point title
    AUC0-t of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a) [7]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing and 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [7] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    1.05 ± 48.5
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [8]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [8] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    3.62 ± 34
        Day 7
    3.77 ± 21.7
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)

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    End point title
    AUC0-t of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) [9]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Collected.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [9] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    0.064 ± 39.8
    0.228 ± 49.1
    0.341 ± 20.4
    1.17 ± 99999
    1.39 ± 35.4
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [10]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [10] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    0.394 ± 51.4
    1.01 ± 52.9
    2.74 ± 36.5
    2.8 ± 45.4
    5.54 ± 40.1
        Day 7
    0.347 ± 36.2
    0.935 ± 36.7
    2.37 ± 43.6
    2.42 ± 46.8
    4.59 ± 22.1
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)

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    End point title
    AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) [11]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [11] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    2 ± 51.7
    3.11 ± 45
        Day 7
    1.82 ± 43.9
    2.88 ± 30.4
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    AUC0-t of MK-3682 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [12]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [12] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    1.05 ± 99999
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [13]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [13] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    3.19 ± 32.8
    4.21 ± 35.2
        Day 7
    2.31 ± 31.8
    3.51 ± 23.2
    No statistical analyses for this end point

    Primary: AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, with Itraconazole (Group F)

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    End point title
    AUC0-t of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, with Itraconazole (Group F) [14]
    End point description
    AUC0-t was calculated using linear log trapezoidal summation from time zero to last measurable concentration. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [14] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    10.6 ± 44
        Day 7
    9.39 ± 46.1
    No statistical analyses for this end point

    Primary: Maximum (Peak) Observed Plasma Drug Concentration (Cmax) of MK-3682 After Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    Maximum (Peak) Observed Plasma Drug Concentration (Cmax) of MK-3682 After Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [15]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [15] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    29.6 ± 45.3
    47.7 ± 54.4
    119 ± 89.2
    1120 ± 47.8
    1530 ± 53.6
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a)

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    End point title
    Cmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a) [16]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [16] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    293 ± 63
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [17]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [17] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    2300 ± 26.6
        Day 7
    2320 ± 19.9
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)

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    End point title
    Cmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) [18]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [18] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    43.6 ± 60.7
    122 ± 26.4
    168 ± 11.4
    510 ± 99999
    667 ± 15.3
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [19]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [19] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    286 ± 77.1
    524 ± 80.1
    1630 ± 58.1
    1360 ± 55.5
    2320 ± 50.2
        Day 7
    199 ± 45.6
    587 ± 34.9
    1250 ± 37.8
    1200 ± 59.4
    2490 ± 25.7
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)

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    End point title
    Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) [20]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [20] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    618 ± 45.2
    778 ± 29.7
        Day 7
    537 ± 56.4
    717 ± 47.2
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    Cmax of MK-3682 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [21]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [21] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    613 ± 99999
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [22]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [22] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    1440 ± 35.9
    1090 ± 34.4
        Day 7
    1550 ± 47.5
    929 ± 26.6
    No statistical analyses for this end point

    Primary: Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, with Itraconazole (Group F)

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    End point title
    Cmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Tablet Formulation in Genotype 1, HCV-Infected Participants, with Itraconazole (Group F) [23]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [23] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    2140 ± 39.4
        Day 7
    1910 ± 42.6
    No statistical analyses for this end point

    Primary: Time to Maximum Plasma Concentration (Tmax) of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Heathy Participants (Group A)

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    End point title
    Time to Maximum Plasma Concentration (Tmax) of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Heathy Participants (Group A) [24]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [24] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: hr
        median (full range (min-max))
    0.8 (0.5 to 1.05)
    1 (0.5 to 3)
    1 (0.5 to 1)
    0.76 (0.5 to 2)
    0.5 (0.5 to 2)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A- Cohort 4a)

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    End point title
    Tmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A- Cohort 4a) [25]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [25] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: hr
        median (full range (min-max))
    3.04 (3 to 4.05)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [26]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [26] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: hr
    median (full range (min-max))
        Day 1
    0.75 (0.5 to 1)
        Day 7
    0.5 (0.5 to 2.03)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)

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    End point title
    Tmax of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B) [27]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [27] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: hr
        median (full range (min-max))
    0.5 (0.5 to 1)
    1 (0.53 to 1)
    1 (0.68 to 1)
    0.76 (0.52 to 1)
    1 (0.5 to 1.08)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)

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    End point title
    Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D) [28]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [28] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: hr
    median (full range (min-max))
        Day 1
    0.85 (0.5 to 2.03)
    0.5 (0.5 to 2)
    0.75 (0.5 to 2)
    1 (0.5 to 4)
    0.5 (0.5 to 2)
        Day 7
    0.97 (0.5 to 1)
    0.5 (0.5 to 1)
    1 (0.5 to 2)
    0.5 (0.48 to 3)
    0.5 (0.5 to 3)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)

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    End point title
    Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C) [29]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [29] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: hr
    median (full range (min-max))
        Day 1
    1 (0.5 to 4)
    2 (0.5 to 3)
        Day 7
    0.5 (0.5 to 3)
    0.5 (0.5 to 3)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [30]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [30] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: hr
    median (full range (min-max))
        Day 1
    1 (0.5 to 3)
    1 (0.5 to 2)
        Day 7
    1 (0.5 to 1)
    1 (0.5 to 2)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Singe Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    Tmax of MK-3682 after Singe Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [31]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [31] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: hr
        median (full range (min-max))
    0.75 (0.5 to 1)
    No statistical analyses for this end point

    Primary: Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, with Itraconazole (Group F)

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    End point title
    Tmax of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, with Itraconazole (Group F) [32]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [32] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: hr
    median (full range (min-max))
        Day 1
    2 (1 to 3)
        Day 7
    1 (1 to 3)
    No statistical analyses for this end point

    Primary: Observed Terminal Half-Life (t1/2) of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    Observed Terminal Half-Life (t1/2) of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [33]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [33] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: hr
        geometric mean (geometric coefficient of variation)
    0.839 ± 27.3
    0.872 ± 33.7
    0.979 ± 36.6
    1.05 ± 25
    1.13 ± 31.6
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Single Dose of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a)

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    End point title
    T1/2 of MK-3682 after Single Dose of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A - Cohort 4a) [34]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [34] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: hr
        geometric mean (geometric coefficient of variation)
    1.63 ± 31.9
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [35]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [35] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: hr
        geometric mean (geometric coefficient of variation)
    2.13 ± 85.4
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B)

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    End point title
    T1/2 of MK-3682 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-infected Participants (Group B) [36]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [36] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: hr
        geometric mean (geometric coefficient of variation)
    1.36 ± 52.7
    0.926 ± 34.5
    1.09 ± 32.5
    1.11 ± 99999
    1.59 ± 1.7
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D)

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    End point title
    T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-infected Participants (Groups C and D) [37]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [37] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: hr
        geometric mean (geometric coefficient of variation)
    1.04 ± 25.1
    1.11 ± 22.5
    1.21 ± 21.7
    1.54 ± 34
    2.58 ± 40.3
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C)

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    End point title
    T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants (Group C) [38]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [38] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: hr
        geometric mean (geometric coefficient of variation)
    2.5 ± 55.9
    3.64 ± 54.8
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    T1/2 of MK-3682 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [39]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [39] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: hr
        geometric mean (geometric coefficient of variation)
    1.16 ± 99999
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [40]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [40] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: hr
        geometric mean (geometric coefficient of variation)
    1.18 ± 27.2
    2.38 ± 34.3
    No statistical analyses for this end point

    Primary: T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, with Itraconazole (Group F)

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    End point title
    T1/2 of MK-3682 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-infected Participants, with Itraconazole (Group F) [41]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [41] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: hr
        geometric mean (geometric coefficient of variation)
    4.3 ± 52.8
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    AUC0-inf of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [42]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [42] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    1.68 ± 47.4
    5.01 ± 27.2
    8.77 ± 8.4
    19.8 ± 12.7
    29.7 ± 32.1
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a)

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    End point title
    AUC0-inf of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a) [43]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [43] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    17.9 ± 13.4
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [44]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [44] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    15.1 ± 16.5
        Day 7
    20.6 ± 17.9
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)

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    End point title
    AUC0-inf of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) [45]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [45] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    2.26 ± 22.3
    5.78 ± 4.7
    7.31 ± 11.1
    17.5 ± 99999
    33.4 ± 37
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [46]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [46] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    4.74 ± 37.6
    8.94 ± 20.2
    14.6 ± 24.3
    14.4 ± 20.8
    19.4 ± 11.1
        Day 7
    7.12 ± 37.6
    12.2 ± 18.9
    19.2 ± 23.1
    19 ± 16.3
    24.4 ± 7.2
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)

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    End point title
    AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) [47]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [47] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    14.7 ± 36.6
    16.1 ± 23.5
        Day 7
    21.4 ± 26.7
    24.7 ± 22.5
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    AUC0-inf of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [48]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [48] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: h·umol/L
        geometric mean (geometric coefficient of variation)
    16.4 ± 99999
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [49]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [49] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    13.4 ± 22.3
    18.4 ± 17
        Day 7
    17.5 ± 23.5
    26.1 ± 26.5
    No statistical analyses for this end point

    Primary: AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F)

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    End point title
    AUC0-inf of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F) [50]
    End point description
    Area under the drug concentration-time curve from time zero to infinity estimated as AUC0-t + Cest/λz, where λz is the terminal elimination rate constant, calculated for the first dose only. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [50] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: h·umol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    13.2 ± 32
        Day 7
    23.8 ± 37
    No statistical analyses for this end point

    Primary: Cmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    Cmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [51]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [51] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    63.2 ± 19.8
    146 ± 13.6
    283 ± 14.7
    758 ± 28.2
    1190 ± 16.6
    No statistical analyses for this end point

    Primary: Cmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a)

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    End point title
    Cmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a) [52]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [52] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    509 ± 8.4
    No statistical analyses for this end point

    Primary: Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [53]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [53] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    1310 ± 7.5
        Day 7
    1630 ± 14.9
    No statistical analyses for this end point

    Primary: Cmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)

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    End point title
    Cmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) [54]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [54] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    55 ± 15
    170 ± 7.2
    279 ± 5.2
    710 ± 99999
    1210 ± 33.8
    No statistical analyses for this end point

    Primary: Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [55]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [55] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    298 ± 34.2
    641 ± 7.6
    1200 ± 20
    1130 ± 22.7
    1560 ± 18.9
        Day 7
    471 ± 33.7
    931 ± 14.4
    1460 ± 21.9
    1420 ± 15.3
    1760 ± 10.4
    No statistical analyses for this end point

    Primary: Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)

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    End point title
    Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) [56]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [56] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    1010 ± 31.5
    1210 ± 21.9
        Day 7
    1420 ± 23.2
    1680 ± 21.5
    No statistical analyses for this end point

    Primary: Cmax of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    Cmax of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [57]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [57] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: nmol/L
        geometric mean (geometric coefficient of variation)
    597 ± 99999
    No statistical analyses for this end point

    Primary: Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [58]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [58] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    1100 ± 11.5
    1180 ± 11.9
        Day 7
    1550 ± 11.4
    1740 ± 19.7
    No statistical analyses for this end point

    Primary: Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F)

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    End point title
    Cmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F) [59]
    End point description
    Maximum observed plasma drug concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [59] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: nmol/L
    geometric mean (geometric coefficient of variation)
        Day 1
    738 ± 31.7
        Day 7
    1180 ± 33.2
    No statistical analyses for this end point

    Primary: Tmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    Tmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [60]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [60] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: hr
        median (full range (min-max))
    3.01 (2 to 6)
    3.5 (2 to 4.05)
    4 (2 to 6)
    2.53 (2 to 6.05)
    3.5 (3 to 4)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a)

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    End point title
    Tmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a) [61]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [61] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: hr
        median (full range (min-max))
    6 (6 to 8)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [62]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [62] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: hr
    median (full range (min-max))
        Day 1
    3 (2 to 3.05)
        Day 7
    2.5 (1 to 4)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)

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    End point title
    Tmax of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) [63]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [63] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: hr
        median (full range (min-max))
    4 (4 to 6)
    4 (3.03 to 4)
    2.05 (2 to 4)
    3.52 (3.03 to 4)
    4 (1 to 6)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [64]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [64] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: hr
    median (full range (min-max))
        Day 1
    4 (1 to 8)
    3 (0.98 to 4)
    3.5 (2 to 4)
    3 (2 to 6)
    4 (3 to 6)
        Day 7
    2 (1.92 to 6)
    2 (1 to 3)
    3.5 (3 to 4)
    3 (1 to 4)
    4 (2 to 4)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)

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    End point title
    Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) [65]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [65] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: hr
    median (full range (min-max))
        Day 1
    4 (2 to 6)
    4 (3 to 6.03)
        Day 7
    4 (2 to 4)
    4 (3 to 6)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    Tmax of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [66]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [66] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: hr
        median (full range (min-max))
    4 (4 to 4)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1,HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1,HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [67]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [67] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: hr
    median (full range (min-max))
        Day 1
    3 (2 to 4)
    4 (3 to 4)
        Day 7
    2 (2 to 4)
    4 (2 to 4)
    No statistical analyses for this end point

    Primary: Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F)

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    End point title
    Tmax of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F) [68]
    End point description
    Time to maximum plasma concentration was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken Day 1: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 1 dose; Day 7: prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post Day 7 dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [68] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: hr
    median (full range (min-max))
        Day 1
    10 (6 to 23.5)
        Day 7
    4 (3 to 8)
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A)

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    End point title
    T1/2 of M6 after Single Dose of MK-3682 as the Capsule Formulation in Healthy Participants (Group A) [69]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted. Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [69] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: hr
        geometric mean (geometric coefficient of variation)
    22.5 ± 6.2
    24.6 ± 12.8
    22.9 ± 14
    29.1 ± 15.5
    28.8 ± 14.2
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a)

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    End point title
    T1/2 of M6 after Single Dose of MK-3682 as the Capsule Formulation in Fed State in Healthy Participants (Group A – Cohort 4a) [70]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [70] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 150 mg (Fed) (Cohort 4a) - PK
    Number of subjects analysed
    6
    Units: hr
        geometric mean (geometric coefficient of variation)
    27.1 ± 9.1
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B)

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    End point title
    T1/2 of M6 after Single Dose of MK-3682 as the Capsule Formulation in Genotype 1, HCV-Infected Participants (Group B) [71]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [71] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 10 mg (Cohort 1b) - PK Group B - MK-3682 25 mg (Cohort 2b) - PK Group B - MK-3682 50 mg (Cohort 3b) - PK Group B - MK-3682 150 mg (Cohort 4b) - PK Group B - MK-3682 300 mg (Cohort 5b) - PK
    Number of subjects analysed
    3
    3
    3
    2
    3
    Units: hr
        geometric mean (geometric coefficient of variation)
    20.1 ± 3.4
    21.2 ± 4.8
    21.7 ± 19.8
    26.9 ± 99999
    28 ± 12.1
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a)

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    End point title
    T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Healthy Participants (Group A – Cohort 6a) [72]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [72] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 300 mg (Cohort 6a) - PK
    Number of subjects analysed
    6
    Units: hr
        geometric mean (geometric coefficient of variation)
    32.2 ± 10.3
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Capsule Formulation in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [73]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [73] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - MK-3682 50 mg (capsule) - PK Groups C and D - MK-3682 150 mg (capsule) - PK Group C - MK-3682 250 mg (capsule) - PK Groups C and D - MK-3682 300 mg (capsule) - PK Group C - MK-3682 400 mg (capsule) - PK
    Number of subjects analysed
    10
    9
    8
    17
    7
    Units: hr
        geometric mean (geometric coefficient of variation)
    25.5 ± 16.8
    28.9 ± 15.2
    30.2 ± 12.3
    32.6 ± 12.7
    35.8 ± 17.8
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C)

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    End point title
    T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants (Group C) [74]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [74] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group C - MK-3682 300 mg (tablet) - PK Group C - MK-3682 450 mg (tablet) - PK
    Number of subjects analysed
    7
    7
    Units: hr
        geometric mean (geometric coefficient of variation)
    32.4 ± 7.7
    30.8 ± 26.8
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e)

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    End point title
    T1/2 of M6 after Single Dose of MK-3682 as Capsule Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 1e) [75]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose. 99999 = Not Calculated.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [75] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 150 mg (Cohort 1e) - PK
    Number of subjects analysed
    2
    Units: hr
        geometric mean (geometric coefficient of variation)
    24 ± 99999
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e)

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    End point title
    T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as Capsule or Tablet Formulation in Genotype 1, HCV-Infected Participants with Mildly Impaired Hepatic Function (Child Pugh Class A) (Group E - Cohort 2e and Cohort 3e) [76]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [76] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group E - MK-3682 300 mg (Cohort 2e) - PK Group E - MK-3682 450 mg (Cohort 3e) - PK
    Number of subjects analysed
    3
    7
    Units: hr
        geometric mean (geometric coefficient of variation)
    27.5 ± 9.3
    26.2 ± 24.8
    No statistical analyses for this end point

    Primary: T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F)

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    End point title
    T1/2 of M6 after Multiple Doses of MK-3682 Once-Daily x 7 Days as the Tablet Formulation in Genotype 1, HCV-Infected Participants, with Intraconazole (Group F) [77]
    End point description
    The time measured for the plasma concentration to decrease by one half (t1/2) was obtained. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). Measurements were taken prior to dosing, 0.5, 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, 36, 48, 72, 96, and 120 hours post dose.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 7 dose
    Notes
    [77] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group F - MK-3682 300 mg (tablet) - PK
    Number of subjects analysed
    8
    Units: hr
        geometric mean (geometric coefficient of variation)
    38.9 ± 17.7
    No statistical analyses for this end point

    Primary: Cumulative Urine Excretion of Unchanged MK-3682 in Healthy Participants (Group A)

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    End point title
    Cumulative Urine Excretion of Unchanged MK-3682 in Healthy Participants (Group A) [78]
    End point description
    Cumulative urine excretion of unchanged MK-3682 in healthy participants was obtained. Urine PK samples were taken on Day 1 prior to dosing (-2 to 0 h), 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, and 96-120 h intervals post dose. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [78] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: umol
        arithmetic mean (standard deviation)
    0.28 ± 0.08
    0.586 ± 0.164
    1.56 ± 0.397
    7.73 ± 4.67
    13.1 ± 4.16
    No statistical analyses for this end point

    Primary: Cumulative Urine Excretion of Unchanged M6 in Healthy Participants (Group A)

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    End point title
    Cumulative Urine Excretion of Unchanged M6 in Healthy Participants (Group A) [79]
    End point description
    Cumulative urine excretion of unchanged M6 in healthy participants was obtained. Urine PK samples were taken on Day 1 prior to dosing (-2 to 0 h), 0-4, 4-8, 8-12, 12-24, 24-48, 48-72, 72-96, and 96-120 h intervals post dose. PK Population: a subpopulation of the per-protocol population, selecting all participants exposed to MK-3682 who had available and evaluable data (e.g., excluding deviations and/or other events that could have an impact on the PK analysis). All participants are fasted.
    End point type
    Primary
    End point timeframe
    Up to 120 hours post Day 1 dose
    Notes
    [79] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group A - MK-3682 10 mg (Cohort 1a) - PK Group A - MK-3682 25 mg (Cohort 2a) - PK Group A - MK-3682 50 mg (Cohort 3a) - PK Group A - MK-3682 150 mg (Cohort 4a) - PK Group A - MK-3682 300 mg (Cohort 5a) - PK
    Number of subjects analysed
    6
    6
    6
    6
    6
    Units: umol
        arithmetic mean (standard deviation)
    5.93 ± 1.42
    15.2 ± 2.5
    31.8 ± 5.69
    101 ± 6.86
    200 ± 37.9
    No statistical analyses for this end point

    Primary: Reduction in Hepatitis C Virus (HCV) RNA from Baseline on Day 8 Following MK-3682 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D)

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    End point title
    Reduction in Hepatitis C Virus (HCV) RNA from Baseline on Day 8 Following MK-3682 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-Infected Participants (Groups C and D) [80]
    End point description
    Reduction in HCV RNA from baseline on Day 8 following MK-3682 50-450 mg for 7 Days in Genotype 1, 2 and 3, HCV-infected participants was obtained. Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model.
    End point type
    Primary
    End point timeframe
    Baseline and Day 8
    Notes
    [80] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Groups C and D - Placebo (pooled) - PP Groups C and D - MK-3682 50 mg (capsule) - PP Groups C and D - MK-3682 150 mg (capsule) - PP Group C - MK-3682 250 mg (capsule) - PP Groups C and D - MK-3682 300 mg (capsule) - PP Group C - MK-3682 400 mg (capsule) - PP Group C - MK-3682 300 mg (tablet) - PP Group C - MK-3682 450 mg (tablet) - PP
    Number of subjects analysed
    8
    10
    9
    8
    17
    7
    7
    7
    Units: log10 IU/mL
        arithmetic mean (standard deviation)
    0.16 ± 0.183
    0.65 ± 0.575
    2.43 ± 0.78
    3.86 ± 0.822
    4.07 ± 0.563
    4.33 ± 0.349
    3.3 ± 0.68
    4.33 ± 0.574
    No statistical analyses for this end point

    Primary: Maximum Reduction in log10 HCV RNA from Baseline - Normal Participants (from Groups B and C) vs. Mild Hepatic Impairment Participants (Group E)

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    End point title
    Maximum Reduction in log10 HCV RNA from Baseline - Normal Participants (from Groups B and C) vs. Mild Hepatic Impairment Participants (Group E) [81]
    End point description
    Maximum reduction in log10 HCV RNA from baseline in normal (non-hepatic impaired) participants vs. participants with mild hepatic impairment was obtained. Per-Protocol Population: participants who complied with the protocol sufficiently to ensure that these data were likely to exhibit the effects of treatment, according to the underlying scientific model. 99999 = Not Applicable.
    End point type
    Primary
    End point timeframe
    Baseline and 28 days after last dose of study drug
    Notes
    [81] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point.
    Justification: Statistical analyses were neither planned nor performed for this endpoint.
    End point values
    Group B - MK-3682 300 mg (Cohort 4b) - PP Group C - MK-3682 300 mg (capsule) - PP Group C - MK-3682 450 mg (tablet) - PP Group E - MK-3682 150 mg (Cohort 1e) - PP Group E - MK-3682 300 mg (Cohort 2e) - PP Group E - MK-3682 450 mg (Cohort 3e) - PP
    Number of subjects analysed
    2
    8
    7
    2
    3
    7
    Units: log10 IU/mL
    arithmetic mean (standard deviation)
        Genotype 1 (pooled 1a + 1b); N=2, 8, 7, 2, 3, 7.
    1.15 ± 0.274
    4.19 ± 0.754
    4.5 ± 0.644
    1.36 ± 0.774
    3.15 ± 0.42
    3.16 ± 0.989
        Genotype 1a; N=1, 3, 2, 0, 2, 1.
    0.96 ± 99999
    4.82 ± 0.504
    5.06 ± 0.489
    99999 ± 99999
    2.92 ± 0.239
    3.6 ± 99999
        Genotype 1b; N=1, 5, 5, 2, 1, 6.
    1.35 ± 99999
    3.82 ± 0.636
    4.28 ± 0.584
    1.36 ± 0.774
    3.59 ± 99999
    3.08 ± 1.06
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 42 days (28 days after last study drug administration)
    Adverse event reporting additional description
    APaT Population: includes all participants who received at least one dose of the study drug. For Cohort 4a, SAEs and NSAEs are given for participants on the fasted regimen.
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    16.1
    Reporting groups
    Reporting group title
    Group A - MK-3682 25 mg (Cohort 2a)
    Reporting group description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 10 mg (Cohort 1a)
    Reporting group description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - Placebo (Cohort 1a -Cohort 5a - pooled)
    Reporting group description
    Participants were administered a single dose of MK-3682-matching placebo as oral capsules under fasted conditions (Cohorts 1a, 2a, 3a, 5a); Participants were administered single doses of MK-3682-matching placebo as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods (Cohort 4a).

    Reporting group title
    Group A - MK-3682 50 mg (Cohort 3a)
    Reporting group description
    Participants were administered a single dose of MK-3682 50 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - MK-3682 150 mg (Cohort 4a)
    Reporting group description
    Participants were administered single doses of MK-3682 150 mg as oral capsules on Days 1 and 7 in a 2-period crossover design (fasted/fed) with a 6 day washout between dosing periods.

    Reporting group title
    Group A - MK-3682 300 mg (Cohort 5a)
    Reporting group description
    Participants were administered a single dose of MK-3682 300 mg as oral capsules under fasted conditions.

    Reporting group title
    Group A - Placebo (Cohort 6a)
    Reporting group description
    Participants were administered single doses of MK-3682-matching placebo as oral capsules for 7 days under fasted conditions.

    Reporting group title
    Group A - MK-3682 300 mg (Cohort 6a)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group B - MK-3682 10 mg (Cohort 1b)
    Reporting group description
    Participants were administered a single dose of MK-3682 10 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 150 mg (Cohort 4b)
    Reporting group description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 50 mg (Cohort 3b)
    Reporting group description
    Participants were administered a single dose of MK-3682 50 mg oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 25 mg (Cohort 2b)
    Reporting group description
    Participants were administered a single dose of MK-3682 25 mg as oral capsules under fasted conditions.

    Reporting group title
    Group B - MK-3682 300 mg (Cohort 5b)
    Reporting group description
    Participants were administered a single dose of MK-3682 300 mg oral capsules under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 50 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 50 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 150 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 150 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 250 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 250 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - MK-3682 300 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 400 mg (capsule)
    Reporting group description
    Participants were administered single doses of MK-3682 400 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 300 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Groups C and D - Placebo (pooled)
    Reporting group description
    Participants administered single doses of MK-3682-matching placebo as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group C - MK-3682 450 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Group E - MK-3682 150 mg (Cohort 1e)
    Reporting group description
    Participants were administered a single dose of MK-3682 150 mg as oral capsules under fasted conditions.

    Reporting group title
    Group E - MK-3682 450 mg (Cohort 3e)
    Reporting group description
    Participants were administered single doses of MK-3682 450 mg as oral tablets once daily for 7 days under fasted conditions.

    Reporting group title
    Group E - MK-3682 300 mg (Cohort 2e)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral capsules once daily for 7 days under fasted conditions.

    Reporting group title
    Group F - MK-3682 300 mg (tablet)
    Reporting group description
    Participants were administered single doses of MK-3682 300 mg as oral tablets once daily for 7 days under fasted conditions. Participants were also administered Itraconazole 200 mg twice daily on Day -5 and 200 mg once daily from Day -4 to Day 11.

    Serious adverse events
    Group A - MK-3682 25 mg (Cohort 2a) Group A - MK-3682 10 mg (Cohort 1a) Group A - Placebo (Cohort 1a -Cohort 5a - pooled) Group A - MK-3682 50 mg (Cohort 3a) Group A - MK-3682 150 mg (Cohort 4a) Group A - MK-3682 300 mg (Cohort 5a) Group A - Placebo (Cohort 6a) Group A - MK-3682 300 mg (Cohort 6a) Group B - MK-3682 10 mg (Cohort 1b) Group B - MK-3682 150 mg (Cohort 4b) Group B - MK-3682 50 mg (Cohort 3b) Group B - MK-3682 25 mg (Cohort 2b) Group B - MK-3682 300 mg (Cohort 5b) Groups C and D - MK-3682 50 mg (capsule) Groups C and D - MK-3682 150 mg (capsule) Group C - MK-3682 250 mg (capsule) Groups C and D - MK-3682 300 mg (capsule) Group C - MK-3682 400 mg (capsule) Group C - MK-3682 300 mg (tablet) Groups C and D - Placebo (pooled) Group C - MK-3682 450 mg (tablet) Group E - MK-3682 150 mg (Cohort 1e) Group E - MK-3682 450 mg (Cohort 3e) Group E - MK-3682 300 mg (Cohort 2e) Group F - MK-3682 300 mg (tablet)
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Group A - MK-3682 25 mg (Cohort 2a) Group A - MK-3682 10 mg (Cohort 1a) Group A - Placebo (Cohort 1a -Cohort 5a - pooled) Group A - MK-3682 50 mg (Cohort 3a) Group A - MK-3682 150 mg (Cohort 4a) Group A - MK-3682 300 mg (Cohort 5a) Group A - Placebo (Cohort 6a) Group A - MK-3682 300 mg (Cohort 6a) Group B - MK-3682 10 mg (Cohort 1b) Group B - MK-3682 150 mg (Cohort 4b) Group B - MK-3682 50 mg (Cohort 3b) Group B - MK-3682 25 mg (Cohort 2b) Group B - MK-3682 300 mg (Cohort 5b) Groups C and D - MK-3682 50 mg (capsule) Groups C and D - MK-3682 150 mg (capsule) Group C - MK-3682 250 mg (capsule) Groups C and D - MK-3682 300 mg (capsule) Group C - MK-3682 400 mg (capsule) Group C - MK-3682 300 mg (tablet) Groups C and D - Placebo (pooled) Group C - MK-3682 450 mg (tablet) Group E - MK-3682 150 mg (Cohort 1e) Group E - MK-3682 450 mg (Cohort 3e) Group E - MK-3682 300 mg (Cohort 2e) Group F - MK-3682 300 mg (tablet)
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 6 (33.33%)
    0 / 6 (0.00%)
    5 / 10 (50.00%)
    2 / 6 (33.33%)
    4 / 6 (66.67%)
    3 / 6 (50.00%)
    1 / 2 (50.00%)
    2 / 6 (33.33%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    1 / 3 (33.33%)
    2 / 3 (66.67%)
    2 / 3 (66.67%)
    8 / 11 (72.73%)
    7 / 10 (70.00%)
    7 / 8 (87.50%)
    8 / 18 (44.44%)
    5 / 8 (62.50%)
    6 / 8 (75.00%)
    6 / 9 (66.67%)
    5 / 8 (62.50%)
    0 / 3 (0.00%)
    5 / 8 (62.50%)
    3 / 3 (100.00%)
    3 / 8 (37.50%)
    Vascular disorders
    Flushing
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    1 / 6 (16.67%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 11 (0.00%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    Hot flush
         subjects affected / exposed
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 10 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
    0 / 6 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 11 (9.09%)
    0 / 10 (0.00%)
    0 / 8 (0.00%)
    0 / 18 (0.00%)
    0 / 8 (0.00%)
    0 / 8 (0.00%)
    0 / 9 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
    0 / 3 (0.00%)
    0 / 8 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    1
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    0
    General disorders and administration site conditions
    Chest discomfort