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    Clinical Trial Results:
    A Randomized, Open-Label, Five Period, Crossover Study to Evaluate the Single Dose Pharmacokinetics and Food Effect of two Pediatric AFQ056 Formulations in Healthy Adults

    Summary
    EudraCT number
    		 2011-000365-12
    Trial protocol
    		 GB  
    Global end of trial date
    05 Jul 2011

    Results information
    Results version number
    		 v1(current)
    This version publication date
    08 Sep 2018
    First version publication date
    08 Sep 2018
    Other versions

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    CAFQ056A2166
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 -
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Novartis Pharma AG
    Sponsor organisation address
    CH 4002, Basel, Switzerland,
    Public contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Scientific contact
    Clinical Disclosure Office, Novartis Pharma AG, +41 613241111,
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-001003-PIP01-10
    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
    05 Jul 2011
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    05 Jul 2011
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    - To evaluate the pharmacokinetics (PKs) of two pediatric formulations relative to the capsule formulation of AFQ056 under fasting conditions at a single dose of 50 milligrams (mg). - To assess the effect of a high fat meal on the relative bioavailability of the two pediatric formulations of AFQ056 at a single dose of 50 mg.
    Protection of trial subjects
    The study was in compliance with the ethical principles derived from the Declaration of Helsinki and the International Conference on Harmonization (ICH) Good Clinical Practice (GCP) Guidelines. All the local regulatory requirements pertinent to safety of trial subjects were also followed during the conduct of the trial.
    Background therapy
    		 -
    Evidence for comparator
    		 For the objective of evaluating the PKs including the relative bioavailability of the two Powder for Oral Suspension (POS) formulations, the Final Market Image (FMI) formulation (hard gelatin capsule at a dose of 50 mg AFQ056) served as the reference.
    Actual start date of recruitment
    06 May 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 Kingdom: 30
    Worldwide total number of subjects
    30
    EEA total number of subjects
    30
    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)
    30
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

    		 Close Top of page
    Recruitment
    Recruitment details
    		 The study was conducted at a single center in United Kingdom.

    Pre-assignment
    Screening details
    		 The study comprised of a screening period of up to 20 days, and five baseline visits (one before each treatment period). Subjects were randomized to one of the five treatment (T) sequences in an allocation ratio of 1:1:1:1:1. It was a single-dose, five period, five treatment, five sequence cross-over study.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Sequence 1: T1-T2-T3-T4-T5
    Arm description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 milliliter (mL) suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-1
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-1 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-2
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-2 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    FMI
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Two 25 mg hard gelatin capsules were administered orally with 240 mL of water in the morning.

    Arm title
    		 Sequence 2: T2-T3-T4-T5-T1
    Arm description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-1
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-1 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-2
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-2 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    FMI
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Two 25 mg hard gelatin capsules were administered orally with 240 mL of water in the morning.

    Arm title
    		 Sequence 3: T3-T4-T5-T1-T2
    Arm description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-1
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-1 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-2
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-2 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    FMI
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Two 25 mg hard gelatin capsules were administered orally with 240 mL of water in the morning.

    Arm title
    		 Sequence 4: T4-T5-T1-T2-T3
    Arm description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.
    Arm type
    		 Experimental

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-2
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-2 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-1
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-1 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    FMI
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Two 25 mg hard gelatin capsules were administered orally with 240 mL of water in the morning.

    Arm title
    		 Sequence 5: T5-T1-T2-T3-T4
    Arm description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.
    Arm type
    		 Active comparator

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-1
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-1 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    POS-2
    Pharmaceutical forms
    Powder for oral suspension
    Routes of administration
    Oral use
    Dosage and administration details
    POS-2 at a dose of 50 mg AFQ056 was administered to subjects as 5 mL suspension with a 5 mL syringe, directly into the subject’s mouth. An additional 235 mL of water was administered immediately after administration of the suspension.

    Investigational medicinal product name
    AFQ056
    Investigational medicinal product code
    Other name
    FMI
    Pharmaceutical forms
    Capsule, hard
    Routes of administration
    Oral use
    Dosage and administration details
    Two 25 mg hard gelatin capsules were administered orally with 240 mL of water in the morning.

    Number of subjects in period 1
    		Sequence 1: T1-T2-T3-T4-T5 Sequence 2: T2-T3-T4-T5-T1 Sequence 3: T3-T4-T5-T1-T2 Sequence 4: T4-T5-T1-T2-T3 Sequence 5: T5-T1-T2-T3-T4
    Started
    6
    6
    6
    6
    6
    Completed
    5
    6
    5
    5
    6
    Not completed
    1
    0
    1
    1
    0
         Abnormal laboratory value(s)
    -
    -
    -
    1
    -
         Administrative problems
    1
    -
    -
    -
    -
         Adverse event
    -
    -
    1
    -
    -

    Baseline characteristics

    		 Close Top of page
    Baseline characteristics reporting groups
    Reporting group title
    Sequence 1: T1-T2-T3-T4-T5
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 milliliter (mL) suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 2: T2-T3-T4-T5-T1
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 3: T3-T4-T5-T1-T2
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 4: T4-T5-T1-T2-T3
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 5: T5-T1-T2-T3-T4
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group values
    		 Sequence 1: T1-T2-T3-T4-T5 Sequence 2: T2-T3-T4-T5-T1 Sequence 3: T3-T4-T5-T1-T2 Sequence 4: T4-T5-T1-T2-T3 Sequence 5: T5-T1-T2-T3-T4 Total
    Number of subjects
    		 6 6 6 6 6 30
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    		 30.8 ( 8.75 ) 37.0 ( 11.61 ) 30.0 ( 11.12 ) 30.3 ( 7.74 ) 35.2 ( 13.23 ) -
    Gender categorical
    Units: Subjects
        Female
    		 0 0 0 0 0 0
        Male
    		 6 6 6 6 6 30

    End points

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    End points reporting groups
    Reporting group title
    Sequence 1: T1-T2-T3-T4-T5
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 milliliter (mL) suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 2: T2-T3-T4-T5-T1
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 3: T3-T4-T5-T1-T2
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 4: T4-T5-T1-T2-T3
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Reporting group title
    Sequence 5: T5-T1-T2-T3-T4
    Reporting group description
    		 Treatment 1: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 2: Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 3: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fasting condition, directly into the mouth on Day 1 of visit. Treatment 4: Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension under fed condition, directly into the mouth on Day 1 of visit. Treatment 5: Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition, on morning of Day 1 visit.

    Subject analysis set title
    Treatment 1: 50mg AFQ056 POS-1, Fasted
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fasting condition, directly into the mouth.

    Subject analysis set title
    Treatment 2: 50 mg AFQ056 POS-1, Fed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fed condition, directly into the mouth.

    Subject analysis set title
    Treatment 3: 50 mg AFQ056 POS-2, Fasted
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fasting condition, directly into the mouth.

    Subject analysis set title
    Treatment 4: 50 mg AFQ056 POS-2, Fed
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fed condition, directly into the mouth.

    Subject analysis set title
    Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Subject analysis set type
    		 Full analysis
    Subject analysis set description
    Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition.

    Primary: Maximum Observed Plasma Concentration (Cmax) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions

    		 Close Top of page
    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    The observed maximum plasma (or serum or blood) concentration following single dose AFQ056 administration was reported (mass / volume). It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    28
    29
    27
    Units: nanogram/mL (ng/mL)
        geometric mean (geometric coefficient of variation)
    149.9 ( 58.94 )
    157.1 ( 47.54 )
    127.8 ( 61.46 )
    Statistical analysis title
    		 AFQ056 POS-1 vs Capsule Formulation
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% Confidence Interval (CI) for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 1: 50mg AFQ056 POS-1, Fasted v Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.179
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.04
         upper limit
    		 1.336
    Statistical analysis title
    		 AFQ056 POS-2 vs Capsule Formulation
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 3: 50 mg AFQ056 POS-2, Fasted v Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.248
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 1.101
         upper limit
    		 1.414

    Primary: Area Under The Plasma Concentration-Time Curve Infinity (AUCinf) of POS-1 and POS-2 Relative to the Capsule Formulation of AFQ056 Under Fasting Conditions

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    End point title
    		 Area Under The Plasma Concentration-Time Curve Infinity (AUCinf) of POS-1 and POS-2 Relative to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    The AUCinf represents area under the plasma (or serum or blood) concentration-time curve from time 0 to infinity (mass * time / volume). It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    27
    28
    23
    Units: hour (hr)*ng/mL
        geometric mean (geometric coefficient of variation)
    832.4 ( 67.19 )
    794.8 ( 58.28 )
    849.8 ( 50.29 )
    Statistical analysis title
    		 AFQ056 POS-1 vs Capsule Formulation
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 1: 50mg AFQ056 POS-1, Fasted v Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects included in analysis
    50
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.047
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.944
         upper limit
    		 1.16
    Statistical analysis title
    		 AFQ056 POS-2 vs Capsule Formulation
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 3: 50 mg AFQ056 POS-2, Fasted v Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects included in analysis
    51
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.005
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.907
         upper limit
    		 1.114

    Primary: Area Under The Plasma Concentration-Time Curve Last (AUClast) of POS-1 and POS-2 Relative to the Capsule Formulation of AFQ056 Under Fasting Conditions

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    End point title
    		 Area Under The Plasma Concentration-Time Curve Last (AUClast) of POS-1 and POS-2 Relative to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    AUClast represents area under the plasma (or serum or blood) concentration-time curve from time 0 to the time of the last quantifiable concentration (mass * time / volume). It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    28
    29
    27
    Units: hr*ng/mL
        geometric mean (geometric coefficient of variation)
    764.7 ( 70.32 )
    736.4 ( 59.29 )
    686.7 ( 68.62 )
    Statistical analysis title
    		 AFQ056 POS-1 vs Capsule Formulation
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 1: 50mg AFQ056 POS-1, Fasted v Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects included in analysis
    55
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.102
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.996
         upper limit
    		 1.218
    Statistical analysis title
    		 AFQ056 POS-2 vs Capsule Formulation
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 3: 50 mg AFQ056 POS-2, Fasted v Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.072
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.97
         upper limit
    		 1.186

    Primary: Effect of Food on the Relative Bioavailability of POS-1 and POS-2 of AFQ056 at a Single Dose as Determined Using Cmax

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    End point title
    		 Effect of Food on the Relative Bioavailability of POS-1 and POS-2 of AFQ056 at a Single Dose as Determined Using Cmax
    End point description
    Bioavailability is the proportion of an administered dose of unchanged drug that reaches the systemic circulation when introduced into the body. Cmax represents observed maximum plasma (or serum or blood) concentration following single dose AFQ056 administration was reported (mass / volume). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects analysed
    28
    28
    29
    28
    Units: ng/mL
        geometric mean (geometric coefficient of variation)
    149.9 ( 58.94 )
    115.2 ( 64.38 )
    157.1 ( 47.54 )
    105.9 ( 57.88 )
    Statistical analysis title
    		 AFQ056 POS-1 Fed vs Fasted
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 1: 50mg AFQ056 POS-1, Fasted v Treatment 2: 50 mg AFQ056 POS-1, Fed
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.77
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.681
         upper limit
    		 0.872
    Statistical analysis title
    		 AFQ056 POS-2 Fed vs Fasted
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 3: 50 mg AFQ056 POS-2, Fasted v Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    0.665
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.586
         upper limit
    		 0.753

    Primary: Effect of Food on the Relative Bioavailability of POS-1 and POS-2 of AFQ056 at a Single Dose as Determined Using AUCinf

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    End point title
    		 Effect of Food on the Relative Bioavailability of POS-1 and POS-2 of AFQ056 at a Single Dose as Determined Using AUCinf
    End point description
    Bioavailability is the proportion of an administered dose of unchanged drug that reaches the systemic circulation when introduced into the body. The AUCinf represents area under the plasma (or serum or blood) concentration-time curve from time 0 to infinity (mass * time / volume). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects analysed
    27
    27
    28
    28
    Units: hr*ng/mL
        geometric mean (geometric coefficient of variation)
    832.4 ( 67.19 )
    876.9 ( 59.38 )
    794.8 ( 58.28 )
    792 ( 65.88 )
    Statistical analysis title
    		 AFQ056 POS-1 Fed vs Fasted
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 1: 50mg AFQ056 POS-1, Fasted v Treatment 2: 50 mg AFQ056 POS-1, Fed
    Number of subjects included in analysis
    54
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.053
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.955
         upper limit
    		 1.161
    Statistical analysis title
    		 AFQ056 POS-2 Fed vs Fasted
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 3: 50 mg AFQ056 POS-2, Fasted v Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.031
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.935
         upper limit
    		 1.136

    Primary: Effect of Food on the Relative Bioavailability of POS-1 and POS-2 of AFQ056 at a Single Dose as Determined Using AUClast

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    End point title
    		 Effect of Food on the Relative Bioavailability of POS-1 and POS-2 of AFQ056 at a Single Dose as Determined Using AUClast
    End point description
    Bioavailability is the proportion of an administered dose of unchanged drug that reaches the systemic circulation when introduced into the body. AUClast represents area under the plasma (or serum or blood) concentration-time curve from time 0 to the time of the last quantifiable concentration (mass * time / volume). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Primary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects analysed
    28
    28
    29
    28
    Units: hr*ng/mL
        geometric mean (geometric coefficient of variation)
    764.7 ( 70.32 )
    820.4 ( 59.78 )
    736.4 ( 59.29 )
    759.5 ( 67.62 )
    Statistical analysis title
    		 AFQ056 POS-1 Fed vs Fasted
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 1: 50mg AFQ056 POS-1, Fasted v Treatment 2: 50 mg AFQ056 POS-1, Fed
    Number of subjects included in analysis
    56
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.077
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.976
         upper limit
    		 1.19
    Statistical analysis title
    		 AFQ056 POS-2 Fed vs Fasted
    Statistical analysis description
    The ratio of geometric means (expressed as a percent) was obtained by exponentiating the mean differences of natural log-transformed data. The 90% CI for the ratio (expressed as a percent) was obtained by exponentiating the CI for the mean differences of natural log-transformed data.
    Comparison groups
    Treatment 3: 50 mg AFQ056 POS-2, Fasted v Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects included in analysis
    57
    Analysis specification
    Pre-specified
    Analysis type
    		 other
    Method
    Parameter type
    		 Ratio of geometric means
    Point estimate
    1.057
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 0.956
         upper limit
    		 1.168

    Secondary: Palatability of POS-1 and POS-2 of AFQ056

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    End point title
    		 Palatability of POS-1 and POS-2 of AFQ056
    End point description
    Palatability implies pleasure provided by foods or fluids, which often varies relative to the homeostatic satisfaction of nutritional, water, or energy needs. The Palatability Assessment was a questionnaire, developed internally at Novartis, to obtain feedback from subjects on the taste, smell and feeling of the powder for oral suspension. Subjects judged the smell, feeling (in mouth), and taste of both POS formulations as: good-very good, somewhat bad-somewhat good, bad, and missing. Analysis was performed on safety analysis set which included all subjects who received at least one dose of the study medication.
    End point type
    Secondary
    End point timeframe
    Day 1: 0 hour (immediately after dosing) in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed
    Number of subjects analysed
    28
    28
    29
    29
    Units: subjects
        Smell: Good – Very good
    5
    3
    7
    7
        Smell: Somewhat bad – Somewhat good
    21
    24
    21
    21
        Smell: Very bad - Bad
    0
    0
    0
    0
        Smell: Missing
    2
    1
    1
    1
        Feeling: Good – Very good
    6
    5
    8
    10
        Feeling: Somewhat bad – Somewhat good
    21
    22
    21
    19
        Feeling: Very bad - Bad
    0
    1
    0
    0
        Feeling: Missing
    1
    0
    0
    0
        Taste: Good – Very good
    5
    5
    8
    9
        Taste: Somewhat bad – Somewhat good
    22
    22
    21
    20
        Taste: Very bad - Bad
    0
    1
    0
    0
        Taste: Missing
    1
    0
    0
    0
    No statistical analyses for this end point

    Secondary: Time to reach the maximum concentration (Tmax) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions

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    End point title
    		 Time to reach the maximum concentration (Tmax) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    The Tmax represents time to reach the maximum concentration after drug administration. It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    28
    28
    29
    28
    27
    Units: Hours
        median (full range (min-max))
    1.50 (0.533 to 2.50)
    4 (1 to 6.02)
    1.50 (0.5 to 2.5)
    4 (1 to 6)
    1 (0.5 to 4)
    No statistical analyses for this end point

    Secondary: Lag time (Tlag) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions

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    End point title
    		 Lag time (Tlag) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    The Tlag represents lag time before the absorption and signifies the delay between the time of dosing and time of appearance of concentration in the sampling. It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    28
    28
    29
    28
    27
    Units: Hours
        median (full range (min-max))
    0.00 (0.00 to 0.00)
    0.00 (0.00 to 0.250)
    0.00 (0.00 to 0.00)
    0.00 (0.00 to 0.250)
    0.25 (0.00 to 0.283)
    No statistical analyses for this end point

    Secondary: Terminal elimination half-life (T1/2) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions

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    End point title
    		 Terminal elimination half-life (T1/2) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    The T1/2 represents terminal elimination half-life defined as time required for the concentration or amount of drug in the body to be reduced by one-half. It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    27
    27
    28
    28
    23
    Units: Hours
        median (full range (min-max))
    8.911 (3.01 to 14.96)
    6.984 (2.35 to 18.08)
    9.839 (2.15 to 20.13)
    6.529 (1.91 to 21.05)
    10.599 (2.77 to 15.74)
    No statistical analyses for this end point

    Secondary: Apparent systemic clearance from plasma (CL/F) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions

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    End point title
    		 Apparent systemic clearance from plasma (CL/F) of POS-1 and POS-2 to the Capsule Formulation of AFQ056 Under Fasting Conditions
    End point description
    The CL/F represents apparent systemic (or total body) clearance from plasma (or serum or blood) following extravascular administration (volume/time). It was determined by non-compartmental method(s) using WinNonlin Pro (Version 5.2). Analysis was performed in PK Analysis set which included subjects who had evaluable PK data for at least one period.
    End point type
    Secondary
    End point timeframe
    Pre-dose, 0.25, 0.5, 1, 1.5, 2, 2.5, 3, 4, 6, 10, 14, 24, 36 and 48 hours in each treatment
    End point values
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Number of subjects analysed
    27
    27
    28
    28
    23
    Units: L/hr
        geometric mean (geometric coefficient of variation)
    60.06 ( 67.19 )
    57.02 ( 59.38 )
    62.91 ( 58.28 )
    63.13 ( 65.88 )
    58.84 ( 50.29 )
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Adverse Events (AEs) were collected from first treatment administration up to 7 days after last drug administration. Serious Adverse Events (SAEs), were collected from informed consent until 30 days after last dose of study drug.
    Adverse event reporting additional description
    The analysis was performed in safety set population defined as all subjects who received study drug and have at least one postbaseline safety assessment were included in the safety data analysis.
    Assessment type
    		 Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    13.0
    Reporting groups
    Reporting group title
    Treatment 1: 50mg AFQ056 POS-1, Fasted
    Reporting group description
    		 Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fasting condition, directly into the mouth.

    Reporting group title
    Treatment 2: 50 mg AFQ056 POS-1, Fed
    Reporting group description
    		 Subjects were administered POS-1 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fed condition, directly into the mouth.

    Reporting group title
    Treatment 3: 50 mg AFQ056 POS-2, Fasted
    Reporting group description
    		 Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fasting condition, directly into the mouth.

    Reporting group title
    Treatment 4: 50 mg AFQ056 POS-2, Fed
    Reporting group description
    		 Subjects were administered POS-2 at a dose of 50 mg AFQ056 as 5 mL suspension with a 5 mL syringe under fed condition, directly into the mouth.

    Reporting group title
    Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Reporting group description
    		 Subjects were administered two 25 mg hard gelatin capsules orally under fasting condition.

    Serious adverse events
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         number of deaths (all causes)
    0
    0
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 Treatment 1: 50mg AFQ056 POS-1, Fasted Treatment 2: 50 mg AFQ056 POS-1, Fed Treatment 3: 50 mg AFQ056 POS-2, Fasted Treatment 4: 50 mg AFQ056 POS-2, Fed Treatment 5: 50 mg AFQ056 Capsule Formulation, Fasted
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    12 / 28 (42.86%)
    8 / 28 (28.57%)
    8 / 29 (27.59%)
    5 / 29 (17.24%)
    10 / 27 (37.04%)
    Investigations
    Blood creatine phosphokinase increased
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Injury, poisoning and procedural complications
    Excoriation
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    Nervous system disorders
    Coordination abnormal
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    0
    0
    Disturbance in attention
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    1 / 29 (3.45%)
    2 / 29 (6.90%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    1
    2
    0
    Dizziness
         subjects affected / exposed
    9 / 28 (32.14%)
    5 / 28 (17.86%)
    6 / 29 (20.69%)
    2 / 29 (6.90%)
    9 / 27 (33.33%)
         occurrences all number
    9
    5
    6
    2
    10
    Dizziness postural
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Headache
         subjects affected / exposed
    3 / 28 (10.71%)
    1 / 28 (3.57%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    2 / 27 (7.41%)
         occurrences all number
    3
    1
    0
    1
    2
    General disorders and administration site conditions
    Non-cardiac chest pain
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    Eye disorders
    Vision blurred
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    1 / 27 (3.70%)
         occurrences all number
    0
    0
    0
    0
    1
    Gastrointestinal disorders
    Diarrhoea
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Hypoaesthesia oral
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Respiratory, thoracic and mediastinal disorders
    Cough
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Nasal obstruction
         subjects affected / exposed
    0 / 28 (0.00%)
    1 / 28 (3.57%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    0
    1
    0
    0
    0
    Skin and subcutaneous tissue disorders
    Eczema
         subjects affected / exposed
    0 / 28 (0.00%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    1 / 29 (3.45%)
    0 / 27 (0.00%)
         occurrences all number
    0
    0
    0
    1
    0
    Psychiatric disorders
    Euphoric mood
         subjects affected / exposed
    1 / 28 (3.57%)
    0 / 28 (0.00%)
    0 / 29 (0.00%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    0
    0
    0
    0
    Infections and infestations
    Nasopharyngitis
         subjects affected / exposed
    1 / 28 (3.57%)
    1 / 28 (3.57%)
    1 / 29 (3.45%)
    0 / 29 (0.00%)
    0 / 27 (0.00%)
         occurrences all number
    1
    1
    1
    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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    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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