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    Clinical Trial Results:
    A Phase 1, Open-Label, Randomized, 2-Panel, 3-Way Crossover Study in Healthy Adult Subjects to Assess the Relative Bioavailability of Simeprevir Following Single Dose Administration of Age-Appropriate Oral Formulation Candidates, Compared to the 150-mg Oral Capsule, and to Assess the Effect of Food on the Bioavailability of Simeprevir Following Single Dose Administration of a Selected Age-Appropriate Oral Formulation Candidate

    Summary
    EudraCT number
    		 2014-005448-17
    Trial protocol
    		 GB  
    Global end of trial date
    09 Sep 2015

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

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TMC435HPC1010
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT02385071
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen Research and Development
    Sponsor organisation address
    Archimedsweg 29-2333CM, Leiden, Netherlands, B235-0
    Public contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen Research and Development, ClinicalTrialsEU@its.jnj.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
    09 Sep 2015
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    09 Sep 2015
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The main objectives of this study were: 1. To compare the rate and extent of absorption of simeprevir (SMV) following administration of a single dose of 2 different oral formulation candidates and following administration of a single dose of the 150 milligram (mg) oral capsule, after a standardized breakfast in healthy adult subjects; 2. To compare the rate and extent of absorption of simeprevir following administration of a single dose of a selected oral formulation candidate in the fed (standardized breakfast) and fasted state in healthy adult subjects; and, 3. To compare the rate and extent of absorption of simeprevir following administration of a single dose of a selected oral formulation candidate after intake with water and after intake with yogurt or apple juice, after a standardized breakfast in healthy adult subjects.
    Protection of trial subjects
    The safety assessments included specific toxicities, clinical laboratory tests (hematology, chemistry and urinalysis), electrocardiogram, vital signs and physical examination. Adverse events were monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    06 May 2015
    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
    United Kingdom: 48
    Worldwide total number of subjects
    48
    EEA total number of subjects
    48
    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)
    48
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 108 subjects were Screened, of whom 60 were not randomized and not treated mainly due to not fulfilling all inclusion or exclusion criteria. In total, 48 subjects were enrolled in Panels 1 and 2 of the study, each containing 24 subjects.

    Period 1
    Period 1 title
    Overall (overall period)
    Is this the baseline period?
    		 Yes
    Allocation method
    Randomised - controlled
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    No

    Arm title
    		 Sequence ABC
    Arm description
    		 Subjects received treatment A (Simeprevir 150 mg [1 * 150 mg] capsule orally once on Day 1) under fed (standardized breakfast) condition followed by treatment B (Simeprevir 150 mg [3 * 50 mg] capsule with minitablets orally once on Day 1) under fed (standardized breakfast) condition followed by treatment C (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Arm title
    		 Sequence BCA
    Arm description
    		 Subjects received treatment B under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Arm title
    		 Sequence CAB
    Arm description
    		 Subjects received treatment C under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Arm title
    		 Sequence CBA
    Arm description
    		 Subjects received treatment C under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Arm title
    		 Sequence BAC
    Arm description
    		 Subjects received treatment B under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Arm title
    		 Sequence ACB
    Arm description
    		 Subjects received treatment A under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Capsule
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Arm title
    		 Sequence DEF
    Arm description
    		 Subjects received treatment D (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment E (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fasted condition followed by treatment F (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast: tablets dispersed in apple juice) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Arm title
    		 Sequence EFD
    Arm description
    		 Subjects received treatment E under fasted condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Arm title
    		 Sequence FDE
    Arm description
    		 Subjects received treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment E under fasted condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Arm title
    		 Sequence FED
    Arm description
    		 Subjects received treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment E under fasted condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Arm title
    		 Sequence EDF
    Arm description
    		 Subjects received treatment E under fasted condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Arm title
    		 Sequence DFE
    Arm description
    		 Subjects received treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment E under fasted condition. The treatment sessions were separated by a washout period of at least 7 days.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Investigational medicinal product name
    Simeprevir
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Number of subjects in period 1
    		Sequence ABC Sequence BCA Sequence CAB Sequence CBA Sequence BAC Sequence ACB Sequence DEF Sequence EFD Sequence FDE Sequence FED Sequence EDF Sequence DFE
    Started
    4
    4
    4
    4
    4
    4
    4
    4
    4
    4
    4
    4
    Completed
    4
    4
    4
    4
    4
    4
    4
    4
    4
    4
    4
    4

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Sequence ABC
    Reporting group description
    		 Subjects received treatment A (Simeprevir 150 mg [1 * 150 mg] capsule orally once on Day 1) under fed (standardized breakfast) condition followed by treatment B (Simeprevir 150 mg [3 * 50 mg] capsule with minitablets orally once on Day 1) under fed (standardized breakfast) condition followed by treatment C (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence BCA
    Reporting group description
    		 Subjects received treatment B under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence CAB
    Reporting group description
    		 Subjects received treatment C under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence CBA
    Reporting group description
    		 Subjects received treatment C under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence BAC
    Reporting group description
    		 Subjects received treatment B under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence ACB
    Reporting group description
    		 Subjects received treatment A under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence DEF
    Reporting group description
    		 Subjects received treatment D (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment E (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fasted condition followed by treatment F (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast: tablets dispersed in apple juice) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence EFD
    Reporting group description
    		 Subjects received treatment E under fasted condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence FDE
    Reporting group description
    		 Subjects received treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment E under fasted condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence FED
    Reporting group description
    		 Subjects received treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment E under fasted condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence EDF
    Reporting group description
    		 Subjects received treatment E under fasted condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence DFE
    Reporting group description
    		 Subjects received treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment E under fasted condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group values
    		 Sequence ABC Sequence BCA Sequence CAB Sequence CBA Sequence BAC Sequence ACB Sequence DEF Sequence EFD Sequence FDE Sequence FED Sequence EDF Sequence DFE Total
    Number of subjects
    		 4 4 4 4 4 4 4 4 4 4 4 4 48
    Title for AgeCategorical
    Units: subjects
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 38.5 ( 16.18 ) 29.8 ( 8.66 ) 29.8 ( 4.11 ) 36.5 ( 12.87 ) 28.8 ( 2.06 ) 25.3 ( 5.97 ) 30.5 ( 5.92 ) 42 ( 7.87 ) 33.8 ( 12.95 ) 44.8 ( 6.18 ) 49.3 ( 7.8 ) 25.8 ( 2.99 ) -
    Title for Gender
    Units: subjects
        Female
    		 1 1 2 1 2 1 3 0 1 3 2 2 19
        Male
    		 3 3 2 3 2 3 1 4 3 1 2 2 29

    End points

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    End points reporting groups
    Reporting group title
    Sequence ABC
    Reporting group description
    		 Subjects received treatment A (Simeprevir 150 mg [1 * 150 mg] capsule orally once on Day 1) under fed (standardized breakfast) condition followed by treatment B (Simeprevir 150 mg [3 * 50 mg] capsule with minitablets orally once on Day 1) under fed (standardized breakfast) condition followed by treatment C (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence BCA
    Reporting group description
    		 Subjects received treatment B under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence CAB
    Reporting group description
    		 Subjects received treatment C under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence CBA
    Reporting group description
    		 Subjects received treatment C under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence BAC
    Reporting group description
    		 Subjects received treatment B under fed (standardized breakfast) condition followed by treatment A under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence ACB
    Reporting group description
    		 Subjects received treatment A under fed (standardized breakfast) condition followed by treatment C under fed (standardized breakfast) condition followed by treatment B under fed (standardized breakfast) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence DEF
    Reporting group description
    		 Subjects received treatment D (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment E (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fasted condition followed by treatment F (Simeprevir 150 mg [3 * 50 mg] dispersible tablets orally once on Day 1) under fed (standardized breakfast: tablets dispersed in apple juice) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence EFD
    Reporting group description
    		 Subjects received treatment E under fasted condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence FDE
    Reporting group description
    		 Subjects received treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment E under fasted condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence FED
    Reporting group description
    		 Subjects received treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment E under fasted condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence EDF
    Reporting group description
    		 Subjects received treatment E under fasted condition followed by treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition. The treatment sessions were separated by a washout period of at least 7 days.

    Reporting group title
    Sequence DFE
    Reporting group description
    		 Subjects received treatment D under fed (standardized breakfast: tablets dispersed in water) condition followed by treatment F under fed (standardized breakfast: tablets dispersed in apple juice) condition followed by treatment E under fasted condition. The treatment sessions were separated by a washout period of at least 7 days.

    Subject analysis set title
    Treatment A
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Subject analysis set title
    Treatment B
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Subject analysis set title
    Treatment C
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Subject analysis set title
    Treatment D
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in water) condition.

    Subject analysis set title
    Treatment E
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Subject analysis set title
    Treatment F
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: tablets dispersed in apple juice) condition.

    Primary: Maximum Observed Plasma Concentration (Cmax) of Simeprevir

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Simeprevir
    End point description
    The Cmax is the maximum observed plasma concentration of Simeprevir. Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72 hours Postdose After Each Treatment Period
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: nanogram per milliliter (ng/ml)
        arithmetic mean (standard deviation)
    1425 ( 599 )
    1271 ( 499 )
    1190 ( 476 )
    1241 ( 556 )
    1143 ( 888 )
    1083 ( 517 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.038
    Method
    		 ANOVA
    Parameter type
    		 Least Square Mean ratio
    Point estimate
    89.97
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 83.94
         upper limit
    		 96.42
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment A v Treatment C
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.038
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    83.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 78.16
         upper limit
    		 89.79
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment C v Treatment B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.038
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    107.39
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 100.2
         upper limit
    		 115.1
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment D v Treatment E
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3182
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    73.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 58.72
         upper limit
    		 91.21
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment D v Treatment F
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3182
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    86.62
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 69.5
         upper limit
    		 107.96
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment F v Treatment E
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.3182
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    84.48
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 67.78
         upper limit
    		 105.3

    Primary: Time to Reach Maximum Observed Plasma Concentration (Tmax) of Simeprevir

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    End point title
    		 Time to Reach Maximum Observed Plasma Concentration (Tmax) of Simeprevir [1]
    End point description
    The Tmax is defined as actual sampling time to reach maximum observed simeprevir concentration. Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72 hours Postdose After Each Treatment Period
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: hour
        median (full range (min-max))
    5.05 (3.97 to 10.07)
    5.02 (4.95 to 8.03)
    6.02 (4.88 to 10.05)
    5.51 (4.97 to 10.03)
    5 (2.98 to 10.02)
    5.49 (2.98 to 10.05)
    No statistical analyses for this end point

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to Last Quantifiable Time (AUC[0-last])
    End point description
    The AUC(0-last) is the area under the plasma concentration-time curve from time zero to last quantifiable time. Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72 hours Postdose After Each Treatment Period
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: nanogram * hour per milliliter (ng.h/ml)
        arithmetic mean (standard deviation)
    15762 ( 6271 )
    14597 ( 6076 )
    13614 ( 5398 )
    15477 ( 7736 )
    12436 ( 8880 )
    13414 ( 6654 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment B v Treatment A
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6727
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    92.31
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 86.63
         upper limit
    		 98.37
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment A v Treatment C
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6727
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    86.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 81.1
         upper limit
    		 92.09
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment C v Treatment B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6727
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    106.82
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 100.24
         upper limit
    		 113.83
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment D v Treatment E
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8528
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    69.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 56.09
         upper limit
    		 85.33
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment D v Treatment F
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8528
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    87.41
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 70.87
         upper limit
    		 107.82
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment F v Treatment E
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8528
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    79.14
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 64.17
         upper limit
    		 97.61

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])

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    End point title
    		 Area Under the Plasma Concentration-Time Curve From Time Zero to Infinite Time (AUC[0-infinity])
    End point description
    The AUC (0-infinity) is the area under the plasma concentration-time curve from time zero to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72 hours Postdose After Each Treatment Period
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: ng.h/ml
        arithmetic mean (standard deviation)
    15889 ( 6362 )
    14691 ( 6117 )
    13709 ( 5454 )
    15693 ( 7974 )
    12547 ( 8938 )
    13599 ( 6810 )
    Statistical analysis title
    		 Statistical Analysis 1
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment A v Treatment B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6386
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    92.22
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 86.55
         upper limit
    		 98.26
    Statistical analysis title
    		 Statistical Analysis 2
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment A v Treatment C
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6386
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    86.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 81.11
         upper limit
    		 92.09
    Statistical analysis title
    		 Statistical Analysis 3
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment C v Treatment B
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.6386
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    106.71
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 100.14
         upper limit
    		 113.7
    Statistical analysis title
    		 Statistical Analysis 4
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment D v Treatment E
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8651
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    69.3
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 56.28
         upper limit
    		 85.34
    Statistical analysis title
    		 Statistical Analysis 5
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment D v Treatment F
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8651
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    87.53
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 71.08
         upper limit
    		 107.79
    Statistical analysis title
    		 Statistical Analysis 6
    Statistical analysis description
    Number of subjects included in analysis was 24 instead of 48.
    Comparison groups
    Treatment F v Treatment E
    Number of subjects included in analysis
    48
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence
    P-value
    		 = 0.8651
    Method
    		 ANOVA
    Parameter type
    		 Least Square Means ratio
    Point estimate
    79.18
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 64.3
         upper limit
    		 97.5

    Primary: Elimination Rate Constant (Lambda[z])

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    End point title
    		 Elimination Rate Constant (Lambda[z]) [2]
    End point description
    Lambda(z) is first-order elimination rate constant associated with the terminal portion of the curve, determined as the negative slope of the terminal log-linear phase of the drug concentration-time curve. Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72 hours Postdose After Each Treatment Period
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: 1 per hour
        arithmetic mean (standard deviation)
    0.0792 ( 0.014 )
    0.079 ( 0.0118 )
    0.0824 ( 0.0195 )
    0.0773 ( 0.019 )
    0.0757 ( 0.0168 )
    0.0761 ( 0.0171 )
    No statistical analyses for this end point

    Primary: Terminal Elimination Half-Life (t1/2 term)

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    End point title
    		 Terminal Elimination Half-Life (t1/2 term) [3]
    End point description
    The terminal elimination half-life (t1/2 term) is the time measured for the plasma concentration to decrease by 1 half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 10, 12, 16, 24, 48 and 72 hours Postdose After Each Treatment Period
    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: Descriptive statistics were done, no inferential statistical analyses were performed.
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: hour
        arithmetic mean (standard deviation)
    9.1 ( 1.9 )
    9 ( 1.4 )
    8.7 ( 1.6 )
    9.6 ( 2.9 )
    9.6 ( 2.3 )
    9.6 ( 2.6 )
    No statistical analyses for this end point

    Secondary: Number of Participants within Each Category of Taste Questionnaire

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    End point title
    		 Number of Participants within Each Category of Taste Questionnaire
    End point description
    Participants were assessed the palatability of the simeprevir formulations by Taste Questionnaire, Question 1 assessed sweetness, bitterness, flavor and overall taste of the formulation; and Question 2 consists of visual analog scale wherein participants were to place a cross in the box beneath the scores, corresponding to the 5-point hedonic scale (dislike it very much; dislike it a little; not sure, like it a little, like it very much). Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Secondary
    End point timeframe
    5 to 15 Minutes Postdose on Day 1 of Each Treatment Period
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: participants
        Sweetness: None
    22
    18
    20
    21
    21
    6
        Sweetness: Weak
    1
    5
    3
    3
    2
    1
        Sweetness: Moderate
    1
    1
    1
    0
    0
    14
        Sweetness: Strong
    0
    0
    0
    0
    1
    3
        Bitterness: None
    22
    10
    12
    12
    13
    14
        Bitterness: Weak
    1
    10
    8
    8
    6
    10
        Bitterness: Moderate
    1
    2
    2
    4
    5
    0
        Bitterness: Strong
    0
    2
    2
    0
    0
    0
        Flavour: None
    23
    11
    10
    17
    20
    7
        Flavour: Weak
    1
    7
    8
    5
    4
    2
        Flavour: Moderate
    0
    4
    4
    2
    0
    12
        Flavour: Strong
    0
    2
    2
    0
    0
    3
        Overall acceptability: Bad
    1
    4
    3
    1
    3
    0
        Overall acceptability: Almost Acceptable
    1
    5
    6
    7
    8
    0
        Overall acceptability: Acceptable
    11
    14
    13
    15
    9
    14
        Overall acceptability: Good
    11
    1
    2
    1
    4
    10
        Hedonic scale: Dislike it Very Much
    0
    4
    3
    1
    3
    0
        Hedonic scale: Dislike it a Little
    1
    4
    8
    9
    7
    1
        Hedonic scale: Not Sure
    12
    8
    7
    8
    9
    6
        Hedonic scale: Like it a Little
    4
    7
    6
    6
    3
    15
        Hedonic scale: Like it Very Much
    7
    1
    0
    0
    2
    2
    No statistical analyses for this end point

    Secondary: Number of Participants with Adverse Events (AEs) and Serious AEs

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    End point title
    		 Number of Participants with Adverse Events (AEs) and Serious AEs
    End point description
    An adverse event (AE) is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. A serious adverse event (SAE) is an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. Intent-to-Treat population included all subjects who received at least 1 dose of any study drug and were summarized separately for Panels 1 and 2 of the study.
    End point type
    Secondary
    End point timeframe
    Screening up to follow-up (7 days after last dose administration)
    End point values
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Number of subjects analysed
    24
    24
    24
    24
    24
    24
    Units: participants
        AEs
    9
    6
    6
    5
    3
    6
        SAEs
    0
    0
    0
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Screening up to 5-7 Days After Last Study Drug Intake or After Dropout
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    18.0
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 Subjects received Simeprevir 150 mg (1 * 150 mg) capsule orally once on Day 1 under fed (standardized breakfast) condition.

    Reporting group title
    Treatment B
    Reporting group description
    		 Subjects received Simeprevir 150 mg (3 * 50 mg) capsule with minitablets orally once on Day 1 under fed (standardized breakfast) condition.

    Reporting group title
    Treatment C
    Reporting group description
    		 Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast) condition.

    Reporting group title
    Treatment D
    Reporting group description
    		 Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: Tablets dispersed in water) condition.

    Reporting group title
    Treatment E
    Reporting group description
    		 Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fasted condition.

    Reporting group title
    Treatment F
    Reporting group description
    		 Subjects received Simeprevir 150 mg (3 * 50 mg) dispersible tablets orally once on Day 1 under fed (standardized breakfast: Tablets dispersed in apple juice) condition.

    Serious adverse events
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment A Treatment B Treatment C Treatment D Treatment E Treatment F
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    9 / 24 (37.50%)
    6 / 24 (25.00%)
    6 / 24 (25.00%)
    5 / 24 (20.83%)
    3 / 24 (12.50%)
    6 / 24 (25.00%)
    Injury, poisoning and procedural complications
    Arthropod Bite
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Wound
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nervous system disorders
    Dizziness
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Dizziness Postural
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Headache
         subjects affected / exposed
    5 / 24 (20.83%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    3 / 24 (12.50%)
         occurrences all number
    7
    1
    0
    0
    0
    3
    Hypoaesthesia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Paraesthesia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    General disorders and administration site conditions
    Asthenia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Feeling Hot
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    0
    0
    0
    1
    Peripheral Swelling
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Immune system disorders
    Seasonal Allergy
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Eye disorders
    Blepharospasm
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Gastrointestinal disorders
    Abdominal Discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Abdominal Distension
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    Abdominal Pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Constipation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Diarrhoea
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    0
    Haematochezia
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Nausea
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    1
    0
    0
    1
    0
    1
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    1
    0
    Nasal Congestion
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Oropharyngeal Pain
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Blister
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Pruritus
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    0
    1
    1
    0
    Skin Irritation
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Psychiatric disorders
    Anxiety
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Insomnia
         subjects affected / exposed
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Arthralgia
         subjects affected / exposed
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    Limb Discomfort
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    Neck Pain
         subjects affected / exposed
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    0 / 24 (0.00%)
    2 / 24 (8.33%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
         occurrences all number
    0
    2
    1
    1
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? No

    Interruptions (globally)
    Were there any global interruptions to the trial? No

    Limitations and caveats
    Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.
    None reported
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