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    Clinical Trial Results:
    A Single-Dose Study to Assess the Pharmacokinetics, Pharmacodynamics, Safety, and Tolerability of Odanacatib in Adolescents and Young Adults Treated with Glucocorticoids

    Summary
    EudraCT number
    		 2012-003414-14
    Trial protocol
    		 Outside EU/EEA   IT   GB   FI  
    Global end of trial date
    14 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    18 Feb 2017
    First version publication date
    18 Feb 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    MK-0822-066
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01630616
    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)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001123-PIP01-11
    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
    14 Jul 2016
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    14 Jul 2016
    Global end of trial reached?
    Yes
    Global end of trial date
    14 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    This study will assess the safety, tolerability, pharmacodynamics, and pharmacokinetics of single doses of odanacatib in mature adolescents and young adults who are currently receiving glucocorticoid therapy. The primary hypotheses of the study are that a single dose of odanacatib is well tolerated in mature adolescents and that following single dose administration of odanacatib 50 mg, there is no clinically important difference in area under the drug-plasma curve from Time 0 to infinity (AUC0-∞) between mature adolescents and young adults.
    Protection of trial subjects
    This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
    Background therapy
    		 Participants received glucocorticoid therapy at a dose stable over the course of the study period and through the poststudy visit. The dose of glucocorticoids 4.5 mg/day, of prednisone or equivalent, other glucocorticoids at the discretion of the investigator after consultation with the sponsor medical monitor.
    Evidence for comparator
    		 -
    Actual start date of recruitment
    21 Mar 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
    Italy: 3
    Country: Number of subjects enrolled
    Korea, Republic of: 6
    Country: Number of subjects enrolled
    Moldova, Republic of: 5
    Country: Number of subjects enrolled
    United Kingdom: 2
    Country: Number of subjects enrolled
    United States: 3
    Worldwide total number of subjects
    19
    EEA total number of subjects
    5
    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)
    11
    Adults (18-64 years)
    8
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 Recruitment continued until the Odanacatib Development Program was discontinued on 02-Sep-2016. No participants were actively receiving treatment at the time of study discontinuation.

    Pre-assignment
    Screening details
    		 The participant was a male or female between the ages of 12 and 17 years of age (inclusive) for adolescents or a male or female between the ages of 18-25 years of age (inclusive) for young adults.

    Period 1
    Period 1 title
    Overall Study (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
    		 Adolescents Odanacatib 10 mg
    Arm description
    		 Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Odanacatib
    Investigational medicinal product code
    Other name
    MK-0822
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast. The dose was given with 240 mL of water.

    Arm title
    		 Adolescents Odanacatib 50 mg
    Arm description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Odanacatib
    Investigational medicinal product code
    Other name
    MK-0822
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast. The dose was given with 240 mL of water.

    Arm title
    		 Adolescents Placebo
    Arm description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to odanacatib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug (single oral dose of placebo) was administered following at least an 8-hour fast. The dose was given with 240 mL of water.

    Arm title
    		 Young Adults Odanacatib 50 mg
    Arm description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Odanacatib
    Investigational medicinal product code
    Other name
    MK-0822
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast. The dose was given with 240 mL of water.

    Arm title
    		 Young Adults Placebo
    Arm description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.
    Arm type
    		 Placebo

    Investigational medicinal product name
    Placebo to odanacatib
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Study drug (single oral dose of placebo) was administered following at least an 8-hour fast. The dose was given with 240 mL of water.

    Number of subjects in period 1
    		Adolescents Odanacatib 10 mg Adolescents Odanacatib 50 mg Adolescents Placebo Young Adults Odanacatib 50 mg Young Adults Placebo
    Started
    5
    3
    3
    6
    2
    Completed
    5
    3
    3
    6
    2

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Adolescents Odanacatib 10 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.

    Reporting group title
    Adolescents Odanacatib 50 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.

    Reporting group title
    Adolescents Placebo
    Reporting group description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.

    Reporting group title
    Young Adults Odanacatib 50 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.

    Reporting group title
    Young Adults Placebo
    Reporting group description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.

    Reporting group values
    		 Adolescents Odanacatib 10 mg Adolescents Odanacatib 50 mg Adolescents Placebo Young Adults Odanacatib 50 mg Young Adults Placebo Total
    Number of subjects
    		 5 3 3 6 2 19
    Age Categorical
    Units: Subjects
        Adolescents (12-17 years)
    		 5 3 3 0 0 11
        Adults (18-64 years)
    		 0 0 0 6 2 8
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 14.8 ± 1.6 15.7 ± 0.6 16.3 ± 0.6 22.3 ± 1.6 20 ± 0 -
    Gender Categorical
    Units: Subjects
        Female
    		 4 2 1 3 2 12
        Male
    		 1 1 2 3 0 7
    Subject analysis sets

    Subject analysis set title
    Young Adults Odanacatib 10 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults. Historical data from study MK-0822-007.

    Subject analysis sets values
    		 Young Adults Odanacatib 10 mg
    Number of subjects
    9
    Age Categorical
    Units: Subjects
        Adolescents (12-17 years)
    0
        Adults (18-64 years)
    9
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    Gender Categorical
    Units: Subjects
        Female
    8
        Male
    1

    End points

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    End points reporting groups
    Reporting group title
    Adolescents Odanacatib 10 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to adolescents.

    Reporting group title
    Adolescents Odanacatib 50 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to adolescents.

    Reporting group title
    Adolescents Placebo
    Reporting group description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to adolescents.

    Reporting group title
    Young Adults Odanacatib 50 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast to young adults.

    Reporting group title
    Young Adults Placebo
    Reporting group description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast to young adults.

    Subject analysis set title
    Young Adults Odanacatib 10 mg
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast to young adults. Historical data from study MK-0822-007.

    Primary: Number of Participants Who Report an Adverse Event (AE)

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    End point title
    		 Number of Participants Who Report an Adverse Event (AE) [1]
    End point description
    An AE is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. The primary population for safety analysis was the Full Analysis Set (FAS) population which consisted of all randomized participants who received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Up to Day 14
    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: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 10 mg Adolescents Odanacatib 50 mg Adolescents Placebo Young Adults Odanacatib 50 mg Young Adults Placebo
    Number of subjects analysed
    5
    3
    3
    6
    2
    Units: Participants
    1
    0
    0
    1
    0
    No statistical analyses for this end point

    Primary: Area Under the Plasma-Drug Concentration Time Curve from Hour 0 to Infinity (AUC0-inf) for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg

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    End point title
    		 Area Under the Plasma-Drug Concentration Time Curve from Hour 0 to Infinity (AUC0-inf) for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg [2] [3]
    End point description
    The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-dose
    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: No statistical analyses were planned or performed for this primary end point.
    [3] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 50 mg Young Adults Odanacatib 50 mg
    Number of subjects analysed
    3
    6
    Units: µM·hr
        geometric mean (geometric coefficient of variation)
    21.6 ± 30.7
    27.2 ± 40.4
    No statistical analyses for this end point

    Primary: Area Under the Plasma-Drug Concentration Time Curve from Hour 0 to 168 hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg

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    End point title
    		 Area Under the Plasma-Drug Concentration Time Curve from Hour 0 to 168 hours (AUC0-168) For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg [4] [5]
    End point description
    The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-dose
    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: No statistical analyses were planned or performed for this primary end point.
    [5] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 50 mg Young Adults Odanacatib 50 mg
    Number of subjects analysed
    3
    6
    Units: µM·hr
        geometric mean (geometric coefficient of variation)
    18.7 ± 24
    21.5 ± 39.8
    No statistical analyses for this end point

    Primary: Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg

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    End point title
    		 Maximum Plasma Concentration (Cmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg [6] [7]
    End point description
    The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment. Cmax is a measure of the maximum amount of drug in the plasma after the dose is given.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-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: No statistical analyses were planned or performed for this primary end point.
    [7] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 50 mg Young Adults Odanacatib 50 mg
    Number of subjects analysed
    3
    6
    Units: nM
        geometric mean (geometric coefficient of variation)
    256 ± 30.8
    237 ± 51.1
    No statistical analyses for this end point

    Primary: Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg

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    End point title
    		 Time to Cmax (Tmax) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg [8] [9]
    End point description
    Tmax is the time required to reach Cmax. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-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: No statistical analyses were planned or performed for this primary end point.
    [9] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 50 mg Young Adults Odanacatib 50 mg
    Number of subjects analysed
    3
    6
    Units: Hours
        median (full range (min-max))
    6 (2 to 24)
    9 (1 to 24)
    No statistical analyses for this end point

    Primary: Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg

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    End point title
    		 Apparent Terminal Half-life (t1/2) of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 50 mg [10] [11]
    End point description
    The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-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: No statistical analyses were planned or performed for this primary end point.
    [11] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 50 mg Young Adults Odanacatib 50 mg
    Number of subjects analysed
    3
    6
    Units: Hours
        geometric mean (geometric coefficient of variation)
    66.9 ± 30.4
    77.3 ± 20.9
    No statistical analyses for this end point

    Primary: AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg

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    End point title
    		 AUC0-inf for Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg [12]
    End point description
    The AUC0-inf data for 10-mg odanacatib in adolescents were compared with the historical young adult AUC0-inf data from study MK-0822-007. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-dose
    Notes
    [12] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 10 mg Young Adults Odanacatib 10 mg
    Number of subjects analysed
    5
    9
    Units: µM·hr
        geometric mean (confidence interval 95%)
    10 (7.5 to 13.3)
    11.3 (9.1 to 13.9)
    Statistical analysis title
    		 Ratio (Adolescents/adults)
    Comparison groups
    Adolescents Odanacatib 10 mg v Young Adults Odanacatib 10 mg
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio (Adolescents/adults)
    Point estimate
    0.89
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.26

    Primary: AUC0-168 For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg

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    End point title
    		 AUC0-168 For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg [13]
    End point description
    The AUC0-168 data for 10-mg odanacatib in adolescents were compared with the historical young adult AUC0-168 data from study MK-0822-007. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-dose
    Notes
    [13] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 10 mg Young Adults Odanacatib 10 mg
    Number of subjects analysed
    5
    9
    Units: µM·hr
        geometric mean (confidence interval 95%)
    8.1 (6.2 to 10.7)
    9.3 (7.6 to 11.4)
    Statistical analysis title
    		 Ratio (Adolescents/Adults)
    Comparison groups
    Adolescents Odanacatib 10 mg v Young Adults Odanacatib 10 mg
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio (Adolescents/Adults)
    Point estimate
    0.87
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.62
         upper limit
    		 1.23

    Primary: Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg

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    End point title
    		 Cmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg [14]
    End point description
    The Cmax data for 10-mg odanacatib in adolescents were compared with the historical young adult Cmax data from study MK-0822-007. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-dose
    Notes
    [14] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 10 mg Young Adults Odanacatib 10 mg
    Number of subjects analysed
    5
    9
    Units: nM
        geometric mean (confidence interval 95%)
    99.6 (75 to 132.4)
    122.3 (99 to 151.1)
    Statistical analysis title
    		 Ratio (Adolescents/Adults)
    Comparison groups
    Adolescents Odanacatib 10 mg v Young Adults Odanacatib 10 mg
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio (Adolescents/Adults)
    Point estimate
    0.81
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.57
         upper limit
    		 1.16

    Primary: Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg

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    End point title
    		 Tmax of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg [15] [16]
    End point description
    Tmax is the time required to reach Cmax. The Tmax data for 10-mg odanacatib in adolescents were compared with the historical young adult Tmax data from study MK-0822-007. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-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: No statistical analyses were planned or performed for this primary end point.
    [16] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 10 mg Young Adults Odanacatib 10 mg
    Number of subjects analysed
    5
    9
    Units: Hours
        median (full range (min-max))
    6 (6 to 24)
    6 (4 to 32)
    No statistical analyses for this end point

    Primary: t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg

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    End point title
    		 t1/2 of Odanacatib For Adolescents and Young Adults Following a Single Oral Dose of Odanacatib 10 mg [17] [18]
    End point description
    The t1/2 data for 10-mg odanacatib in adolescents were compared with the historical young adult t1/2 data from study MK-0822-007. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Primary
    End point timeframe
    Hour 0 (predose), and at 1, 2, 6, 8, 24, 96, 168, 240, and 336 hours post-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: No statistical analyses were planned or performed for this primary end point.
    [18] - The end point is not reporting statistics for all the arms in the baseline period. It is expected all the baseline period arms will be reported on when providing values for an end point on the baseline period.
    Justification: No statistical analyses were planned or performed for this primary end point.
    End point values
    		 Adolescents Odanacatib 10 mg Young Adults Odanacatib 10 mg
    Number of subjects analysed
    5
    9
    Units: Hours
        geometric mean (geometric coefficient of variation)
    80.5 ± 17.9
    73 ± 23.4
    No statistical analyses for this end point

    Secondary: Change from Baseline in Inhibition of Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) to 168 Hours Postdose

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    End point title
    		 Change from Baseline in Inhibition of Urinary Aminoterminal Crosslinked Telopeptide of Type 1 Collagen (uNTx/Cr) to 168 Hours Postdose
    End point description
    Urinary aminoterminal crosslinked telopeptide of Type I collagen (uNTx/Cr) is a biochemical marker of bone resorption. The primary analysis dataset included all participants who were compliant with the protocol sufficiently to ensure that these data would likely exhibit the effects of treatment, according to the underlying scientific model, and had available data from at least one treatment.
    End point type
    Secondary
    End point timeframe
    Baseline (predose Day 1) and 168 hours postdose
    End point values
    		 Adolescents Odanacatib 10 mg Adolescents Odanacatib 50 mg Adolescents Placebo Young Adults Odanacatib 50 mg Young Adults Placebo
    Number of subjects analysed
    5
    3
    3
    6
    2
    Units: nmol[BCE]/mmol[creatinine])
        geometric mean (geometric coefficient of variation)
    0.79 ± 50.68
    0.4 ± 232
    1.03 ± 3.39
    0.36 ± 53.62
    0.83 ± 13.53
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 14 days
    Adverse event reporting additional description
    The primary population for safety analysis was the FAS population which consisted of all randomized participants who received at least 1 dose of study drug.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.1
    Reporting groups
    Reporting group title
    Adolescents Odanacatib 10 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 10 mg) was administered following at least an 8-hour fast.

    Reporting group title
    Adolescents Odanacatib 50 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast.

    Reporting group title
    Adolescents Placebo
    Reporting group description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast.

    Reporting group title
    Young Adults Odanacatib 50 mg
    Reporting group description
    		 Study drug (single oral dose of odanacatib 50 mg) was administered following at least an 8-hour fast.

    Reporting group title
    Young Adults Placebo
    Reporting group description
    		 Study drug (single oral dose of placebo) was administered following at least an 8-hour fast.

    Serious adverse events
    		 Adolescents Odanacatib 10 mg Adolescents Odanacatib 50 mg Adolescents Placebo Young Adults Odanacatib 50 mg Young Adults Placebo
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Adolescents Odanacatib 10 mg Adolescents Odanacatib 50 mg Adolescents Placebo Young Adults Odanacatib 50 mg Young Adults Placebo
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
    Investigations
    Blood potassium increased
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Renal and urinary disorders
    Nephrotic syndrome
         subjects affected / exposed
    1 / 5 (20.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    0 / 6 (0.00%)
    0 / 2 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Musculoskeletal and connective tissue disorders
    Systemic lupus erythematosis
         subjects affected / exposed
    0 / 5 (0.00%)
    0 / 3 (0.00%)
    0 / 3 (0.00%)
    1 / 6 (16.67%)
    0 / 2 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    18 Nov 2013
    AM1 - Addition of Panel C (participants receiving a single oral dose of odanacatib 50 mg or placebo 8 participants (6 active 2 placebo), 18 to 25 years of age and reduction in the duration of prior concomitant therapy with glucocorticoid.
    02 May 2014
    AM3 - Modified sample criteria: attempt to enroll at least 2 rather than 3 of each gender at each dose level and changes to some PK/PD time points.
    17 Sep 2015
    AM5 - The diet plan was modified and fasting requirements were added for pharmacokinetic and pharmacodynamic sampling. The washout periods for the prior therapy with cyclosporine and bisphosphonates were reduced. Oral contraceptive use was now permitted. Instruction for use of the emergency unblinding call center was added.

    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.
    This study was terminated early due to the discontinuation of the Odanacatib Development Program on 02-Sep-2016 and only a small number of participants were enrolled. The number of PK time points was reduced to 8 to 11 per Ethics Committee requests.
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    The status and protocol content of GB trials is no longer updated since 1 January 2021. For the UK, as of 31 January 2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI. Legal notice
    As of 31 January 2023, all EU/EEA initial clinical trial applications must be submitted through CTIS . Updated EudraCT trials information and information on PIP/Art 46 trials conducted exclusively in third countries continues to be submitted through EudraCT and published on this website.

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