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    Clinical Trial Results:
    A Study of the Comparative Bioavailability of Two Second-Generation Investigational Pediatric Oral Granule Formulations of MK-1439 Compared to the Adult Formulation

    Summary
    EudraCT number
    		 2016-004656-30
    Trial protocol
    		 Outside EU/EEA  
    Global end of trial date
    26 Jul 2016

    Results information
    Results version number
    		 v1(current)
    This version publication date
    11 Aug 2017
    First version publication date
    11 Aug 2017
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    1439-052
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    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-001676-PIP01-14
    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
    26 Jul 2016
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Jul 2016
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objectives of the study are as follows: 1. To evaluate the comparative bioavailability of the MK-1439 100 mg adult formulation tablets under fasting conditions to MK-1439 100 mg investigational oral pediatric uncoated and coated granule formulation under fasting conditions; 2. To evaluate the comparative bioavailability of the MK-1439 100 mg oral pediatric uncoated granule formulation under fasting conditions to MK-1439 100 mg investigational oral pediatric uncoated granule formulation when given with vanilla pudding and with applesauce; 3. To evaluate the comparative bioavailability of the MK-1439 100 mg investigational oral pediatric coated granule formulation under fasting conditions to MK-1439 100 mg investigational oral pediatric uncoated granule formulation when given with vanilla pudding and with applesauce.
    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
    20 May 2016
    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
    Canada: 24
    Worldwide total number of subjects
    24
    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)
    24
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 This is an open-label, single-dose, partially randomized, five-period, seven treatment, six-sequence, crossover, comparative bioavailability study. Each participant was assigned to 1 of 6 treatment sequences.

    Pre-assignment
    Screening details
    		 Study was to enroll healthy, non-smoking, male and female subjects, from 18 to 55 years of age. Other inclusion and exclusion criteria applied.

    Period 1
    Period 1 title
    Period 1
    Is this the baseline period?
    		 Yes
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A→B→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 Adult formulation (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence A→C→B→X→W
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 Adult formulation (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→A→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→C→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→A→B→Y→Z
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→B→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered after an overnight fast of at least 10 hours

    Number of subjects in period 1
    		Sequence A→B→C→W→X Sequence A→C→B→X→W Sequence B→A→C→W→X Sequence B→C→A→Z→Y Sequence C→A→B→Y→Z Sequence C→B→A→Z→Y
    Started
    4
    4
    4
    4
    4
    4
    Completed
    4
    4
    4
    4
    4
    4
    Period 2
    Period 2 title
    Period 2
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A→B→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg pediatric uncoated oral granules formulation (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence A→C→B→X→W
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→A→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 Adult formulation (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→C→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→A→B→Y→Z
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 Adult formulation (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→B→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered after an overnight fast of at least 10 hours

    Number of subjects in period 2
    		Sequence A→B→C→W→X Sequence A→C→B→X→W Sequence B→A→C→W→X Sequence B→C→A→Z→Y Sequence C→A→B→Y→Z Sequence C→B→A→Z→Y
    Started
    4
    4
    4
    4
    4
    4
    Completed
    4
    4
    4
    4
    4
    3
    Not completed
    0
    0
    0
    0
    0
    1
         Suspected multiple study participation
    -
    -
    -
    -
    -
    1
    Period 3
    Period 3 title
    Period 3
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A→B→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence A→C→B→X→W
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→A→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation (Treatment C)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→C→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 Adult formulation (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→A→B→Y→Z
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation (Treatment B)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→B→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 Adult formulation (Treatment A)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose administered after an overnight fast of at least 10 hours

    Number of subjects in period 3
    		Sequence A→B→C→W→X Sequence A→C→B→X→W Sequence B→A→C→W→X Sequence B→C→A→Z→Y Sequence C→A→B→Y→Z Sequence C→B→A→Z→Y
    Started
    4
    4
    4
    4
    4
    3
    Completed
    4
    4
    4
    4
    4
    3
    Period 4
    Period 4 title
    Period 4
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A→B→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation with vanilla pudding (Treatment W)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered with vanilla pudding after an overnight fast of at least 10 hours

    Arm title
    		 Sequence A→C→B→X→W
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation with applesauce (Treatment X)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered with apple sauce after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→A→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation with vanilla pudding (Treatment W)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered with vanilla pudding after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→C→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation with applesauce (Treatment Z)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered with apple sauce after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→A→B→Y→Z
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation with vanilla pudding (Treatment Y)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered with vanilla pudding after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→B→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation with applesauce (Treatment Z)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered with apple sauce after an overnight fast of at least 10 hours

    Number of subjects in period 4
    		Sequence A→B→C→W→X Sequence A→C→B→X→W Sequence B→A→C→W→X Sequence B→C→A→Z→Y Sequence C→A→B→Y→Z Sequence C→B→A→Z→Y
    Started
    4
    4
    4
    4
    4
    3
    Completed
    4
    4
    4
    4
    4
    2
    Not completed
    0
    0
    0
    0
    0
    1
         Adverse event, non-fatal
    -
    -
    -
    -
    -
    1
    Period 5
    Period 5 title
    Period 5
    Is this the baseline period?
    		 No
    Allocation method
    Not applicable
    Blinding used
    		 Not blinded

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence A→B→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation with applesauce (Treatment X)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered with apple sauce after an overnight fast of at least 10 hours

    Arm title
    		 Sequence A→C→B→X→W
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated oral granules formulation with vanilla pudding (Treatment W)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered with vanilla pudding after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→A→C→W→X
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric uncoated granules formulation with applesauce (Treatment X)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of uncoated granules administered with apple sauce after an overnight fast of at least 10 hours

    Arm title
    		 Sequence B→C→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation with vanilla pudding (Treatment Y)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered with vanilla pudding after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→A→B→Y→Z
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation with applesauce (Treatment Z)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered with apple sauce after an overnight fast of at least 10 hours

    Arm title
    		 Sequence C→B→A→Z→Y
    Arm description
    		 -
    Arm type
    		 Experimental

    Investigational medicinal product name
    MK-1439 100 mg (0.8 mg/granule) pediatric coated oral granules formulation with vanilla pudding (Treatment Y)
    Investigational medicinal product code
    Other name
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Single oral 100 mg dose of coated granules administered with vanilla pudding after an overnight fast of at least 10 hours

    Number of subjects in period 5
    		Sequence A→B→C→W→X Sequence A→C→B→X→W Sequence B→A→C→W→X Sequence B→C→A→Z→Y Sequence C→A→B→Y→Z Sequence C→B→A→Z→Y
    Started
    4
    4
    4
    4
    4
    2
    Completed
    4
    4
    4
    4
    4
    2

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Period 1
    Reporting group description
    		 All enrolled participants regardless of assigned sequence.

    Reporting group values
    		 Period 1 Total
    Number of subjects
    		 24
    Age Categorical
    Units: Subjects
    Age Continuous
    Units: years
        arithmetic mean (standard deviation)
    		 41 ( 11 ) -
    Gender Categorical
    Units: Subjects
        Female
    		 11 11
        Male
    		 13 13

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Sequence A→B→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence A→C→B→X→W
    Reporting group description
    		 -

    Reporting group title
    Sequence B→A→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence B→C→A→Z→Y
    Reporting group description
    		 -

    Reporting group title
    Sequence C→A→B→Y→Z
    Reporting group description
    		 -

    Reporting group title
    Sequence C→B→A→Z→Y
    Reporting group description
    		 -
    Reporting group title
    Sequence A→B→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence A→C→B→X→W
    Reporting group description
    		 -

    Reporting group title
    Sequence B→A→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence B→C→A→Z→Y
    Reporting group description
    		 -

    Reporting group title
    Sequence C→A→B→Y→Z
    Reporting group description
    		 -

    Reporting group title
    Sequence C→B→A→Z→Y
    Reporting group description
    		 -
    Reporting group title
    Sequence A→B→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence A→C→B→X→W
    Reporting group description
    		 -

    Reporting group title
    Sequence B→A→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence B→C→A→Z→Y
    Reporting group description
    		 -

    Reporting group title
    Sequence C→A→B→Y→Z
    Reporting group description
    		 -

    Reporting group title
    Sequence C→B→A→Z→Y
    Reporting group description
    		 -
    Reporting group title
    Sequence A→B→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence A→C→B→X→W
    Reporting group description
    		 -

    Reporting group title
    Sequence B→A→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence B→C→A→Z→Y
    Reporting group description
    		 -

    Reporting group title
    Sequence C→A→B→Y→Z
    Reporting group description
    		 -

    Reporting group title
    Sequence C→B→A→Z→Y
    Reporting group description
    		 -
    Reporting group title
    Sequence A→B→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence A→C→B→X→W
    Reporting group description
    		 -

    Reporting group title
    Sequence B→A→C→W→X
    Reporting group description
    		 -

    Reporting group title
    Sequence B→C→A→Z→Y
    Reporting group description
    		 -

    Reporting group title
    Sequence C→A→B→Y→Z
    Reporting group description
    		 -

    Reporting group title
    Sequence C→B→A→Z→Y
    Reporting group description
    		 -

    Subject analysis set title
    MK-1439 Adult Tablet (Treatment A)- Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received single dose of 1 adult 100 mg tablet administered after an overnight fast of at least 10 hours regardless of assigned sequence.

    Subject analysis set title
    Uncoated Granules (Treatment B) - Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received a single dose of 100 mg pediatric uncoated oral granules administered after an overnight fast of at least 10 hours regardless of assigned sequence.

    Subject analysis set title
    Coated Granules (Treatment C) - Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received a single dose of 100 mg pediatric coated oral granules administered after an overnight fast of at least 10 hours regardless of assigned sequence.

    Subject analysis set title
    Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received 1 dose of 100 mg uncoated oral granules administered with vanilla pudding after an overnight fast of at least 10 hours regardless of assigned sequence

    Subject analysis set title
    Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received 1 dose of 100 mg uncoated oral granules administered with apple sauce after an overnight fast of at least 10 hours regardless of assigned sequence

    Subject analysis set title
    Coated Granules with Vanilla Pudding (Treatment Y) - Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received 1 dose of 100 mg coated oral granules administered with vanilla pudding after an overnight fast of at least 10 hours regardless of assigned sequence

    Subject analysis set title
    Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    All participants that received 1 dose of 100 mg coated oral granules administered with apple sauce after an overnight fast of at least 10 hours regardless of assigned sequence

    Primary: Area Under the Concentration Curve from 0 to infinity (AUCinf) of MK-1439 Following Single Oral Dose Administration of 100 mg Adult Tablet, 100 mg Pediatric Uncoated Granules and 100 mg Pediatric Coated Granules Under Fasted Conditions

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    End point title
    		 Area Under the Concentration Curve from 0 to infinity (AUCinf) of MK-1439 Following Single Oral Dose Administration of 100 mg Adult Tablet, 100 mg Pediatric Uncoated Granules and 100 mg Pediatric Coated Granules Under Fasted Conditions
    End point description
    Blood samples drawn prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration to determine the AUCinf
    End point type
    Primary
    End point timeframe
    Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration
    End point values
    		 MK-1439 Adult Tablet (Treatment A)- Pooled Uncoated Granules (Treatment B) - Pooled Coated Granules (Treatment C) - Pooled
    Number of subjects analysed
    23
    24
    24
    Units: hr·μM
        geometric mean (confidence interval 95%)
    43.1 (37.7 to 49.3)
    39.6 (34.3 to 45.7)
    38.5 (33.9 to 43.7)
    Statistical analysis title
    		 Uncoated Granules vs. Adult Tablet
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    MK-1439 Adult Tablet (Treatment A)- Pooled v Uncoated Granules (Treatment B) - Pooled
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Geometric Mean Ratio (GMR)
    Point estimate
    0.92
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.87
         upper limit
    		 0.97
    Statistical analysis title
    		 Coated Granules vs. Adult Tablet
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    MK-1439 Adult Tablet (Treatment A)- Pooled v Coated Granules (Treatment C) - Pooled
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.89
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.85
         upper limit
    		 0.94

    Primary: Maximum Concentration (Cmax) of MK-1439 Following Single Oral Dose Administration of 100 mg Adult Tablet, 100 mg Pediatric Uncoated Granules and 100 mg Pediatric Coated Granules Under Fasted Conditions

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    End point title
    		 Maximum Concentration (Cmax) of MK-1439 Following Single Oral Dose Administration of 100 mg Adult Tablet, 100 mg Pediatric Uncoated Granules and 100 mg Pediatric Coated Granules Under Fasted Conditions
    End point description
    Blood samples drawn prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration to determine the AUCinf.
    End point type
    Primary
    End point timeframe
    Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration
    End point values
    		 MK-1439 Adult Tablet (Treatment A)- Pooled Uncoated Granules (Treatment B) - Pooled Coated Granules (Treatment C) - Pooled
    Number of subjects analysed
    23
    24
    24
    Units: nM
        geometric mean (confidence interval 95%)
    2100 (1880 to 2340)
    1950 (1780 to 2140)
    1610 (1440 to 1790)
    Statistical analysis title
    		 Uncoated Granules vs. Adult Tablet
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    MK-1439 Adult Tablet (Treatment A)- Pooled v Uncoated Granules (Treatment B) - Pooled
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.93
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.86
         upper limit
    		 1.01
    Statistical analysis title
    		 Coated Granules vs. Adult Tablet
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    MK-1439 Adult Tablet (Treatment A)- Pooled v Coated Granules (Treatment C) - Pooled
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.7
         upper limit
    		 0.84

    Primary: Concentration at 24 hours Post Dose (C24) of MK-1439 Following Single Oral Dose Administration of 100 mg Adult Tablet, 100 mg Pediatric Uncoated Granules and 100 mg Pediatric Coated Granules Under Fasted Conditions

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    End point title
    		 Concentration at 24 hours Post Dose (C24) of MK-1439 Following Single Oral Dose Administration of 100 mg Adult Tablet, 100 mg Pediatric Uncoated Granules and 100 mg Pediatric Coated Granules Under Fasted Conditions
    End point description
    Blood sample taken at 24 hours post dose to determine the concentration of MK-1439
    End point type
    Primary
    End point timeframe
    24 hours post dose
    End point values
    		 MK-1439 Adult Tablet (Treatment A)- Pooled Uncoated Granules (Treatment B) - Pooled Coated Granules (Treatment C) - Pooled
    Number of subjects analysed
    23
    24
    24
    Units: nM
        geometric mean (confidence interval 95%)
    650 (556 to 759)
    622 (527 to 735)
    615 (541 to 700)
    Statistical analysis title
    		 Uncoated Granules vs. Adult Tablet
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    MK-1439 Adult Tablet (Treatment A)- Pooled v Uncoated Granules (Treatment B) - Pooled
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.96
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.9
         upper limit
    		 1.02
    Statistical analysis title
    		 Coated Granules vs. Adult Tablet
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    MK-1439 Adult Tablet (Treatment A)- Pooled v Coated Granules (Treatment C) - Pooled
    Number of subjects included in analysis
    47
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.95
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.89
         upper limit
    		 1.01

    Primary: Area Under the Concentration Curve from 0 to infinity (AUCinf) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Uncoated Granules Alone, with Vanilla Pudding or with Apple Sauce

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    End point title
    		 Area Under the Concentration Curve from 0 to infinity (AUCinf) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Uncoated Granules Alone, with Vanilla Pudding or with Apple Sauce
    End point description
    Blood samples drawn prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration to determine the AUCinf
    End point type
    Primary
    End point timeframe
    Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration
    End point values
    		 Uncoated Granules (Treatment B) - Pooled Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Number of subjects analysed
    24
    12
    12
    Units: hr·μM
        geometric mean (confidence interval 95%)
    39.6 (34.3 to 45.7)
    43.7 (37.1 to 51.5)
    51.2 (43.9 to 59.7)
    Statistical analysis title
    		 Uncoated Granules With Pudding vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Uncoated Granules (Treatment B) - Pooled v Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.1
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.02
         upper limit
    		 1.19
    Statistical analysis title
    		 Uncoated Granules With Apple Sauce vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Uncoated Granules (Treatment B) - Pooled v Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.29
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.2
         upper limit
    		 1.39

    Primary: Maximum Concentration (Cmax) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Uncoated Granules Alone, with Vanilla Pudding or with Apple Sauce

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    End point title
    		 Maximum Concentration (Cmax) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Uncoated Granules Alone, with Vanilla Pudding or with Apple Sauce
    End point description
    Blood samples drawn prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration to determine the Cmax
    End point type
    Primary
    End point timeframe
    Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration
    End point values
    		 Uncoated Granules (Treatment B) - Pooled Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Number of subjects analysed
    24
    12
    12
    Units: nM
        geometric mean (confidence interval 95%)
    1950 (1780 to 2140)
    2030 (1750 to 2360)
    3040 (2750 to 3370)
    Statistical analysis title
    		 Uncoated Granules With Pudding vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Uncoated Granules (Treatment B) - Pooled v Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.93
         upper limit
    		 1.17
    Statistical analysis title
    		 Uncoated Granules With Apple Sauce vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Uncoated Granules (Treatment B) - Pooled v Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.56
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.43
         upper limit
    		 1.7

    Primary: Concentration at 24 hours Post Dose (C24) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Uncoated Granules Alone, with Vanilla Pudding or with Apple Sauce

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    End point title
    		 Concentration at 24 hours Post Dose (C24) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Uncoated Granules Alone, with Vanilla Pudding or with Apple Sauce
    End point description
    Blood sample drawn at 24 hours post dose to determine the C24
    End point type
    Primary
    End point timeframe
    24 hours post dose
    End point values
    		 Uncoated Granules (Treatment B) - Pooled Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Number of subjects analysed
    24
    12
    12
    Units: nM
        geometric mean (confidence interval 95%)
    622 (527 to 735)
    645 (539 to 773)
    743 (615 to 899)
    Statistical analysis title
    		 Uncoated Granules With Pudding vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Uncoated Granules (Treatment B) - Pooled v Uncoated Granules with Vanilla Pudding (Treatment W) - Pooled
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.04
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.95
         upper limit
    		 1.13
    Statistical analysis title
    		 Uncoated Granules With Apple Sauce vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Uncoated Granules (Treatment B) - Pooled v Uncoated Granules with Apple Sauce (Treatment X) - Pooled
    Number of subjects included in analysis
    36
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.2
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.09
         upper limit
    		 1.31

    Primary: Area Under the Concentration Curve from 0 to infinity (AUCinf) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Coated Granules Alone, with Vanilla Pudding or with Apple Sauce

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    End point title
    		 Area Under the Concentration Curve from 0 to infinity (AUCinf) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Coated Granules Alone, with Vanilla Pudding or with Apple Sauce
    End point description
    Blood samples drawn prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration to determine the AUCinf
    End point type
    Primary
    End point timeframe
    Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration
    End point values
    		 Coated Granules (Treatment C) - Pooled Coated Granules with Vanilla Pudding (Treatment Y) - Pooled Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Number of subjects analysed
    24
    10
    11
    Units: hr·μM
        geometric mean (confidence interval 95%)
    38.5 (33.9 to 43.7)
    38.1 (32.3 to 44.9)
    48.4 (42.5 to 55.1)
    Statistical analysis title
    		 Coated Granules With Pudding vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Coated Granules (Treatment C) - Pooled v Coated Granules with Vanilla Pudding (Treatment Y) - Pooled
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.99
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.91
         upper limit
    		 1.07
    Statistical analysis title
    		 Uncoated Granules With Apple Sauce vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Coated Granules (Treatment C) - Pooled v Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.26
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.18
         upper limit
    		 1.34

    Primary: Maximum Concentration (Cmax) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Coated Granules Alone, with Vanilla Pudding or with Apple Sauce

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    End point title
    		 Maximum Concentration (Cmax) of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Coated Granules Alone, with Vanilla Pudding or with Apple Sauce
    End point description
    Blood samples drawn prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration to determine the Cmax
    End point type
    Primary
    End point timeframe
    Prior to dosing (0-hour) and 0.5, 1, 1.5, 2, 2.5, 3, 4, 5, 6, 12, 24, 48, and 72 hours after drug administration
    End point values
    		 Coated Granules (Treatment C) - Pooled Coated Granules with Vanilla Pudding (Treatment Y) - Pooled Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Number of subjects analysed
    24
    10
    11
    Units: nM
        geometric mean (confidence interval 95%)
    1610 (1440 to 1790)
    1460 (1230 to 1730)
    2560 (2390 to 2760)
    Statistical analysis title
    		 Coated Granules With Pudding vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Coated Granules (Treatment C) - Pooled v Coated Granules with Vanilla Pudding (Treatment Y) - Pooled
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.9
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.79
         upper limit
    		 1.03
    Statistical analysis title
    		 Coated Granules With Apple Sauce vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Coated Granules (Treatment C) - Pooled v Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.59
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.47
         upper limit
    		 1.73

    Primary: Concentration at 24 hours Post Dose (C24)of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Coated Granules Alone, with Vanilla Pudding or with Apple Sauce

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    End point title
    		 Concentration at 24 hours Post Dose (C24)of MK-1439 Following Single Oral Dose Administration of MK-1439 100 mg Pediatric Coated Granules Alone, with Vanilla Pudding or with Apple Sauce
    End point description
    Blood sample drawn at 24 hours after drug administration to determine the C24
    End point type
    Primary
    End point timeframe
    24 hours post dose
    End point values
    		 Coated Granules (Treatment C) - Pooled Coated Granules with Vanilla Pudding (Treatment Y) - Pooled Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Number of subjects analysed
    24
    10
    11
    Units: nM
        geometric mean (confidence interval 95%)
    615 (541 to 700)
    588 (502 to 689)
    745 (641 to 866)
    Statistical analysis title
    		 Coated Granules With Pudding vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Coated Granules (Treatment C) - Pooled v Coated Granules with Vanilla Pudding (Treatment Y) - Pooled
    Number of subjects included in analysis
    34
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    0.96
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.88
         upper limit
    		 1.04
    Statistical analysis title
    		 Coated Granules With Apple Sauce vs Without
    Statistical analysis description
    Back-transformed least-squares mean difference and confidence interval from linear mixed-effects model performed on natural log-transformed values
    Comparison groups
    Coated Granules (Treatment C) - Pooled v Coated Granules with Apple Sauce (Treatment Z) - Pooled
    Number of subjects included in analysis
    35
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 GMR
    Point estimate
    1.21
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.12
         upper limit
    		 1.3

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    up to 14 days post last dose
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    19.0
    Reporting groups
    Reporting group title
    Treatment A
    Reporting group description
    		 All participants that received single dose of 1 adult 100 mg tablet administered after an overnight fast of at least 10 hours regardless of assigned sequence.

    Reporting group title
    Treatment B
    Reporting group description
    		 All participants that received a single dose of 125 pediatric uncoated oral granules administered after an overnight fast of at least 10 hours regardless of assigned sequence.

    Reporting group title
    Treatment C
    Reporting group description
    		 All participants that received a single dose of 125 pediatric coated oral granules administered after an overnight fast of at least 10 hours regardless of assigned sequence.

    Reporting group title
    Treatment W
    Reporting group description
    		 All participants that received 1 dose of 125 uncoated oral granules administered with vanilla pudding after an overnight fast of at least 10 hours regardless of assigned sequence

    Reporting group title
    Treatment X
    Reporting group description
    		 All participants that received 1 dose of 125 uncoated oral granules administered with apple sauce after an overnight fast of at least 10 hours regardless of assigned sequence

    Reporting group title
    Treatment Y
    Reporting group description
    		 All participants that received 1 dose of 125 coated oral granules administered with vanilla pudding after an overnight fast of at least 10 hours regardless of assigned sequence

    Reporting group title
    Treatment Z
    Reporting group description
    		 All participants that received 1 dose of 125 coated oral granules administered with apple sauce after an overnight fast of at least 10 hours regardless of assigned sequence

    Serious adverse events
    		 Treatment A Treatment B Treatment C Treatment W Treatment X Treatment Y Treatment Z
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (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: 0%
    Non-serious adverse events
    		 Treatment A Treatment B Treatment C Treatment W Treatment X Treatment Y Treatment Z
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    0 / 23 (0.00%)
    7 / 24 (29.17%)
    7 / 24 (29.17%)
    0 / 12 (0.00%)
    5 / 12 (41.67%)
    3 / 10 (30.00%)
    0 / 11 (0.00%)
    Nervous system disorders
    Headache
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    1
    0
    0
    0
    0
    Somnolence
         subjects affected / exposed
    0 / 23 (0.00%)
    2 / 24 (8.33%)
    2 / 24 (8.33%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    2
    2
    0
    1
    1
    0
    General disorders and administration site conditions
    Catheter site related reaction
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Fatigue
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    1 / 10 (10.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    0
    1
    0
    Gastrointestinal disorders
    Dry mouth
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    1 / 12 (8.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    0
    0
    1
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    0 / 23 (0.00%)
    5 / 24 (20.83%)
    4 / 24 (16.67%)
    0 / 12 (0.00%)
    4 / 12 (33.33%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    5
    4
    0
    4
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Rhinorrhoea
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Throat irritation
         subjects affected / exposed
    0 / 23 (0.00%)
    1 / 24 (4.17%)
    0 / 24 (0.00%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Erythema
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    0
    0
    Pruritus
         subjects affected / exposed
    0 / 23 (0.00%)
    0 / 24 (0.00%)
    1 / 24 (4.17%)
    0 / 12 (0.00%)
    0 / 12 (0.00%)
    0 / 10 (0.00%)
    0 / 11 (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? 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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    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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