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    Clinical Trial Results:
    A Single Dose Biocomparison Study to Assess Two Pediatric Formulations of MK-8669 to the Provisional Market Formulation in Healthy Subjects

    Summary
    EudraCT number
    		 2011-003433-33
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    28 Jan 2012

    Results information
    Results version number
    		 v1(current)
    This version publication date
    20 Jan 2017
    First version publication date
    20 Jan 2017
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    8669-060
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Merck Sharp & Dohme Corp
    Sponsor organisation address
    One Merck Drive, Whitehouse Station, New Jersey, United States, 08889-0100
    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-000458-PIP01-08
    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
    28 Jan 2012
    Is this the analysis of the primary completion data?
    Yes
    Primary completion date
    28 Jan 2012
    Global end of trial reached?
    Yes
    Global end of trial date
    28 Jan 2012
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To evaluate the whole blood pharmacokinetics and comparative bioavailability of ridaforolimus (MK-8669) administered as three different formulations in healthy male study participants. Pharmacokinetic measurements included area under the concentration-time curve from time 0 to infinity (AUC0-inf) and maximum concentration (Cmax) of ridaforomilus. The pharmacokinetic data were compared between the provisional market 10 mg enteric-coated tablet (ECT), enteric-coated granules (ECG), and uncoated granules (UG) in the fasted state, and between ECG and UG in the fed state.
    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
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    15 Sep 2011
    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 States: 21
    Worldwide total number of subjects
    21
    EEA total number of subjects
    0
    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)
    21
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 Within approximately 2 to 4 weeks prior to administration of the initial dose of study drug, potential participants were evaluated to determine that they fulfilled the entry requirements.

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

    Arms
    Arm title
    		 All Treated Participants
    Arm description
    		 In Periods 1 to 3, participants were randomized to receive 1 of 3 oral treatments in the fasted state: 40 mg ridaforolimus ECT (Treatment A); 40 mg ridaforolimus ECG (Treatment B); 40 mg ridaforolimus UG (Treatment C). In Period 4, participants were administered either ECG or UG following a high-fat meal. Each period was 14 days in duration; single-dose administration was followed by at least a 2 week washout period between doses.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Ridaforomilus 40 mg ECT (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Coated tablet
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg (4 x 10 mg enteric-coated tablets) administered orally as a single dose

    Investigational medicinal product name
    Ridaforolimus 40 mg ECG (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg enteric-coated granules administered orally as a single dose

    Investigational medicinal product name
    Ridaforolimus 40 mg UG (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    40 mg uncoated granules administered orally as a single dose

    Number of subjects in period 1
    		All Treated Participants
    Started
    21
    Completed
    17
    Not completed
    4
         Missed treatment
    1
         Withdrawal
    3

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Overall Study
    Reporting group description
    		 -

    Reporting group values
    		 Overall Study Total
    Number of subjects
    		 21 21
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 34 ± 10 -
    Gender Categorical
    Units: Subjects
        Female
    		 0 0
        Male
    		 21 21
    Subject analysis sets

    Subject analysis set title
    Ridaforolimus ECT (Trt A): Fasted
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECT under fasting conditions and had available PK data

    Subject analysis set title
    Ridaforolimus ECG (Trt B): Fasted
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECG under fasting conditions and had available PK data

    Subject analysis set title
    Ridaforomilus UG (Trt C): Fasted
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus UG under fasting conditions and had available PK data

    Subject analysis set title
    Ridaforolimus ECG (Trt B): Fasted [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECG under fasting conditions, and had available PK data for both fasting and fed states.

    Subject analysis set title
    Ridaforolimus ECG (Trt B): Fed [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECG under fed conditions, and had available PK data for both fasting and fed states.

    Subject analysis set title
    Ridaforolimus UG (Trt C): Fasted [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus UG under fasting conditions, and had available PK data for both fasting and fed states.

    Subject analysis set title
    Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus UG under fed conditions, and had available PK data for both fasting and fed states.

    Subject analysis sets values
    		 Ridaforolimus ECT (Trt A): Fasted Ridaforolimus ECG (Trt B): Fasted Ridaforomilus UG (Trt C): Fasted Ridaforolimus ECG (Trt B): Fasted [Food effect analysis] Ridaforolimus ECG (Trt B): Fed [Food effect analysis] Ridaforolimus UG (Trt C): Fasted [Food effect analysis] Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Number of subjects
    19
    19
    19
    7
    7
    10
    10
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    ±
    ±
    ±
    ±
    ±
    ±
    ±
    Gender Categorical
    Units: Subjects
        Female
    0
    0
    0
    0
    0
    0
    0
        Male
    19
    19
    19
    7
    7
    10
    10

    End points

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    End points reporting groups
    Reporting group title
    All Treated Participants
    Reporting group description
    		 In Periods 1 to 3, participants were randomized to receive 1 of 3 oral treatments in the fasted state: 40 mg ridaforolimus ECT (Treatment A); 40 mg ridaforolimus ECG (Treatment B); 40 mg ridaforolimus UG (Treatment C). In Period 4, participants were administered either ECG or UG following a high-fat meal. Each period was 14 days in duration; single-dose administration was followed by at least a 2 week washout period between doses.

    Subject analysis set title
    Ridaforolimus ECT (Trt A): Fasted
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECT under fasting conditions and had available PK data

    Subject analysis set title
    Ridaforolimus ECG (Trt B): Fasted
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECG under fasting conditions and had available PK data

    Subject analysis set title
    Ridaforomilus UG (Trt C): Fasted
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus UG under fasting conditions and had available PK data

    Subject analysis set title
    Ridaforolimus ECG (Trt B): Fasted [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECG under fasting conditions, and had available PK data for both fasting and fed states.

    Subject analysis set title
    Ridaforolimus ECG (Trt B): Fed [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus ECG under fed conditions, and had available PK data for both fasting and fed states.

    Subject analysis set title
    Ridaforolimus UG (Trt C): Fasted [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus UG under fasting conditions, and had available PK data for both fasting and fed states.

    Subject analysis set title
    Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Healthy adult males who received a single 40 mg oral dose of ridaforolimus UG under fed conditions, and had available PK data for both fasting and fed states.

    Primary: Area Under the Concentration-Time Curve of Single Dose (40 mg) Ridaforolimus from Time 0 to Infinity (AUC0-inf)

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    End point title
    		 Area Under the Concentration-Time Curve of Single Dose (40 mg) Ridaforolimus from Time 0 to Infinity (AUC0-inf)
    End point description
    Whole blood samples for determination of ridaforolimus concentrations were collected at predose and specified time points over 168 hours following the ridaforolimus dose under fasting conditions in each treatment period.
    End point type
    Primary
    End point timeframe
    For Periods 1, 2, 3, and 4: Predose (0) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose
    End point values
    		 Ridaforolimus ECT (Trt A): Fasted Ridaforolimus ECG (Trt B): Fasted Ridaforomilus UG (Trt C): Fasted
    Number of subjects analysed
    19
    19
    18 [1]
    Units: ng•hr/mL
        geometric mean (confidence interval 95%)
    2387.05 (1850.18 to 3079.7)
    1571.17 (1222.71 to 2018.94)
    2075.12 (1857.33 to 2318.45)
    Notes
    [1] - One participant did not complete Period 1 and was excluded from statistical analysis for AUC0-inf.
    Statistical analysis title
    		 AUC 0-inf: ECG (TrT B) vs. ECT (TrT A), fasted
    Statistical analysis description
    Geometric mean (GM) values and variance components arising from a linear mixed-effects model were used to determine the geometric mean ratio (GMR) of AUC0-inf for ridaforolimus ECG versus ridaforolimus ECT under fasting conditions. The ECG and ECT formulations were considered comparable if the GMR was within pre-specified confidence-interval (CI) bounds (0.70, 1.43).
    Comparison groups
    Ridaforolimus ECT (Trt A): Fasted v Ridaforolimus ECG (Trt B): Fasted
    Number of subjects included in analysis
    38
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [2]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.66
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.48
         upper limit
    		 0.9
    Notes
    [2] - The same 19 participants were treated in the TrT A and TrT B groups. The analysis was based on 38 observations from 19 participants, not on 38 participants.
    Statistical analysis title
    		 AUC 0-inf: UG (TrT C) vs. ECT (TrT A), fasted
    Statistical analysis description
    GM values and variance components arising from a linear mixed-effects model were used to determine the GMR of AUC0-inf for ridaforolimus UG versus ridaforolimus ECT under fasting conditions. The UG and ECT formulations were considered comparable if the GMR was within pre-specified confidence-interval (CI) bounds (0.70, 1.43)
    Comparison groups
    Ridaforolimus ECT (Trt A): Fasted v Ridaforomilus UG (Trt C): Fasted
    Number of subjects included in analysis
    37
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [3]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.87
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.73
         upper limit
    		 1.04
    Notes
    [3] - The same 18 to 19 participants were treated in the TrT A and TrT C groups. The analysis was based on 37 observations from 18 to 19 participants, not on 37 participants.

    Secondary: AUC0-inf of Ridaforolimus ECG (Treatment B): Fasted versus Fed States

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    End point title
    		 AUC0-inf of Ridaforolimus ECG (Treatment B): Fasted versus Fed States
    End point description
    Whole blood samples for determination of ridaforolimus concentrations were collected at predose and specified time points over 168 hours following the ridaforolimus dose in each treatment period. Area under the curve from time 0 to infinity (AUC0-inf) was analyzed following administration of a single 40 mg dose of ridaforolimus ECG under fasting conditions during Periods 1, 2, and 3, and under fed conditions during Period 4. ECT and UG formulations were not included in this analysis.
    End point type
    Secondary
    End point timeframe
    For Periods 1, 2, 3, and 4: Predose (0) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose
    End point values
    		 Ridaforolimus ECG (Trt B): Fasted [Food effect analysis] Ridaforolimus ECG (Trt B): Fed [Food effect analysis]
    Number of subjects analysed
    7
    7
    Units: ng•hr/mL
        geometric mean (confidence interval 95%)
    1949.56 (1505.06 to 2525.34)
    1359.27 (1049.36 to 1760.71)
    Statistical analysis title
    		 AUC 0-inf: ECG (TrT B), Fasted vs. Fed
    Statistical analysis description
    To estimate food effect on whole blood AUC0-inf of 40 mg ridaforolimus ECG, the least squares (LS) mean and corresponding 90% CI for difference in log-transformed AUC0-inf (Fed – Fasted) was calculated from the model using the mean square error and referencing a t-distribution. Mean difference on the log-scale and CI was exponentiated to obtain the AUC0-inf GMR and 90% CIs (Fed / Fasted).
    Comparison groups
    Ridaforolimus ECG (Trt B): Fasted [Food effect analysis] v Ridaforolimus ECG (Trt B): Fed [Food effect analysis]
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [4]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.7
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.52
         upper limit
    		 0.93
    Notes
    [4] - The same 7 participants were treated in the TrT B fasted and fed groups. The analysis was based on 14 observations from 7 participants, not on 14 participants.

    Secondary: Maximum Concentration (Cmax) of Ridaforolimus ECG (Treatment B): Fasted versus Fed States

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    End point title
    		 Maximum Concentration (Cmax) of Ridaforolimus ECG (Treatment B): Fasted versus Fed States
    End point description
    Whole blood samples for determination of ridaforolimus concentrations were collected at predose and specified time points over 168 hours following the ridaforolimus dose in each treatment period. Maximum concentration (Cmax) was analysed following administration of ridaforolimus 40 mg ECG under fasting conditions during Periods 1, 2, and 3, and under fed conditions during Period 4.
    End point type
    Secondary
    End point timeframe
    For Periods 1, 2, 3, and 4: Predose (0) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose
    End point values
    		 Ridaforolimus ECG (Trt B): Fasted [Food effect analysis] Ridaforolimus ECG (Trt B): Fed [Food effect analysis]
    Number of subjects analysed
    7
    7
    Units: ng/mL
        geometric mean (confidence interval 95%)
    189.94 (130.14 to 277.22)
    83.9 (57.48 to 122.45)
    Statistical analysis title
    		 Cmax: ECG (TrT B), Fasted vs. Fed
    Statistical analysis description
    To estimate food effect on whole blood Cmax of 40 mg ridaforolimus ECG, the LS mean and corresponding 90% CI for difference in log-transformed Cmax (Fed – Fasted) was calculated from the model using the mean square error and referencing a t-distribution. Mean difference on the log-scale and CI was exponentiated to obtain the Cmax GMR and 90% CIs (Fed / Fasted).
    Comparison groups
    Ridaforolimus ECG (Trt B): Fasted [Food effect analysis] v Ridaforolimus ECG (Trt B): Fed [Food effect analysis]
    Number of subjects included in analysis
    14
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [5]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.44
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.31
         upper limit
    		 0.64
    Notes
    [5] - The same 7 participants were treated in the TrT B fasted and fed groups. The analysis was based on 14 observations from 7 participants, not on 14 participants.

    Secondary: AUC0-inf of Ridaforolimus UG (Treatment C): Fasted versus Fed States

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    End point title
    		 AUC0-inf of Ridaforolimus UG (Treatment C): Fasted versus Fed States
    End point description
    Whole blood samples for determination of ridaforolimus concentrations were collected at predose and specified time points over 168 hours following the ridaforolimus dose in each treatment period. Area under the curve from time 0 to infinity (AUC0-inf) was analysed following administration of ridaforolimus 40 mg UG under fasting conditions during Periods 1, 2, and 3, and under fed conditions during Period 4.
    End point type
    Secondary
    End point timeframe
    For Periods 1, 2, 3, and 4: Predose (0) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose
    End point values
    		 Ridaforolimus UG (Trt C): Fasted [Food effect analysis] Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Number of subjects analysed
    10
    10
    Units: ng•hr/mL
        geometric mean (confidence interval 95%)
    2211.29 (1814.93 to 2694.21)
    1664.81 (1366.4 to 2028.38)
    Statistical analysis title
    		 AUC 0-inf: UG (TrT C), Fasted vs. Fed
    Statistical analysis description
    To estimate food effect on whole blood Cmax of 40 mg ridaforolimus ECG, the LS mean and corresponding 90% CI for difference in log-transformed Cmax (Fed – Fasted) was calculated from the model using the mean square error and referencing a t-distribution. Mean difference on the log-scale and CI was exponentiated to obtain the Cmax GMR and 90% CIs (Fed / Fasted).
    Comparison groups
    Ridaforolimus UG (Trt C): Fasted [Food effect analysis] v Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [6]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.75
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.68
         upper limit
    		 0.84
    Notes
    [6] - The same 10 participants were treated in the TrT C fasted and fed groups. The analysis was based on 20 observations from 10 participants, not on 20 participants.

    Secondary: Cmax of Ridaforolimus UG (Trt C): Fasted versus Fed States

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    End point title
    		 Cmax of Ridaforolimus UG (Trt C): Fasted versus Fed States
    End point description
    Whole blood samples for determination of ridaforolimus concentrations were collected at predose and specified time points over 168 hours following the ridaforolimus dose in each treatment period. Maximum concentration (Cmax) was analysed following administration of ridaforolimus 40 mg UG in under fasting conditions during Periods 1, 2, and 3, and under fed conditions during Period 4.
    End point type
    Secondary
    End point timeframe
    For Periods 1, 2, 3, and 4: Predose (0) and 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 16, 24, 36, 48, 72, 96, and 168 hours postdose.
    End point values
    		 Ridaforolimus UG (Trt C): Fasted [Food effect analysis] Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Number of subjects analysed
    10
    10
    Units: ng/mL
        geometric mean (confidence interval 95%)
    178.16 (146.12 to 217.23)
    93.55 (76.73 to 114.07)
    Statistical analysis title
    		 Cmax: UG (TrT C), Fasted vs. Fed
    Statistical analysis description
    To estimate food effect on whole blood Cmax of 40 mg ridaforolimus UG, the LS mean and corresponding 90% CI for difference in log-transformed Cmax (Fed – Fasted) was calculated from the model using the mean square error and referencing a t-distribution. Mean difference on the log-scale and CI was exponentiated to obtain the Cmax GMR and 90% CIs (Fed / Fasted).
    Comparison groups
    Ridaforolimus UG (Trt C): Fasted [Food effect analysis] v Ridaforomilus UG (Trt C): Fed [Food effect analysis]
    Number of subjects included in analysis
    20
    Analysis specification
    Pre-specified
    Analysis type
    		 equivalence [7]
    Method
    Parameter type
    		 GMR
    Point estimate
    0.53
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.44
         upper limit
    		 0.62
    Notes
    [7] - The same 10 participants were treated in the TrT C fasted and fed groups. The analysis was based on 20 observations from 10 participants, not on 20 participants.

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    From beginning of treatment (Day 1) to treatment Week 4 in Period 1, Period 2, Period 3, and Period 4, and for a poststudy evaluation before the end of approximately 10 weeks
    Adverse event reporting additional description
    An adverse experience was any unfavorable and unintended change in the structure, function, or chemistry of the body temporally associated with the use of the SPONSOR’s product, whether or not considered related to the use of the product.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    14.1
    Reporting groups
    Reporting group title
    Ridaforolimus ECT (Trt A)-Fasted
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus ECT under fasting conditions

    Reporting group title
    Ridaforolimus ECG (Trt B)-Fasted
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus ECG under fasting conditions

    Reporting group title
    Ridaforolimus UG (Trt C)-Fasted
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus UG under fasting conditions

    Reporting group title
    Ridaforolimus ECG (Trt B)-Fed Light
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus ECG in Period 4 following a light breakfast

    Reporting group title
    Ridaforolimus UG (Trt C)-Fed Light
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus UG in Period 4 following a light breakfast

    Reporting group title
    Ridaforolimus ECG (Trt B)-Fed Full
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus ECG in Period 4 following a high-fat breakfast

    Reporting group title
    Ridaforolimus UG (Trt C)-Fed Full
    Reporting group description
    		 Healthy adult males that received a single 40 mg oral dose of ridaforolimus UG in Period 4 following a high-fat breakfast

    Serious adverse events
    		 Ridaforolimus ECT (Trt A)-Fasted Ridaforolimus ECG (Trt B)-Fasted Ridaforolimus UG (Trt C)-Fasted Ridaforolimus ECG (Trt B)-Fed Light Ridaforolimus UG (Trt C)-Fed Light Ridaforolimus ECG (Trt B)-Fed Full Ridaforolimus UG (Trt C)-Fed Full
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 5%
    Non-serious adverse events
    		 Ridaforolimus ECT (Trt A)-Fasted Ridaforolimus ECG (Trt B)-Fasted Ridaforolimus UG (Trt C)-Fasted Ridaforolimus ECG (Trt B)-Fed Light Ridaforolimus UG (Trt C)-Fed Light Ridaforolimus ECG (Trt B)-Fed Full Ridaforolimus UG (Trt C)-Fed Full
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 19 (31.58%)
    3 / 19 (15.79%)
    3 / 19 (15.79%)
    0 / 2 (0.00%)
    2 / 5 (40.00%)
    1 / 7 (14.29%)
    2 / 10 (20.00%)
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    4 / 19 (21.05%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    4
    0
    0
    0
    1
    0
    1
    Gastrointestinal disorders
    APHTHOUS STOMATITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    DRY MOUTH
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    DYSPEPSIA
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    STOMATITIS
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    TONGUE ULCERATION
         subjects affected / exposed
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    1
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    COUGH
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    1 / 7 (14.29%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    1
    0
    NASAL CONGESTION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    0
    1
    OROPHARYNGEAL PAIN
         subjects affected / exposed
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    SINUS CONGESTION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    1 / 7 (14.29%)
    1 / 10 (10.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    1
    THROAT IRRITATION
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    1 / 5 (20.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Skin and subcutaneous tissue disorders
    PAPULE
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    PRURITUS
         subjects affected / exposed
    1 / 19 (5.26%)
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    0
    0
    RASH MACULAR
         subjects affected / exposed
    0 / 19 (0.00%)
    0 / 19 (0.00%)
    1 / 19 (5.26%)
    0 / 2 (0.00%)
    0 / 5 (0.00%)
    0 / 7 (0.00%)
    0 / 10 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    17 Oct 2011
    Amendment 1 specified revised study eligibility criteria and clarified the study flow chart
    09 Jan 2012
    Amendment 2 incorporated flexibility to repeat a treatment period, if deemed necessary by the Sponsor.

    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.
    Caveat: 7 of 21 participants had a light breakfast rather than a protocol-defined high-fat breakfast prior to blood sampling in Period 4. However, these participants were re-dosed and repeated the period after the proper high-fat breakfast.
    For support, Contact us.
    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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