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    Clinical Trial Results:
    A Phase 1, open-label, randomized, 3-way crossover study in 3 panels of healthy, adult subjects to assess the relative bioavailability of TMC207 following single-dose administration of two pediatric formulations using a 100-mg tablet formulation as the reference, with and without food.

    Due to a system error, the data reported in v1 is not correct and has been removed from public view.
    Summary
    EudraCT number
    		 2012-005492-13
    Trial protocol
    		 NL  
    Global end of trial date
    26 Aug 2013

    Results information
    Results version number
    		 v2(current)
    This version publication date
    15 Jul 2016
    First version publication date
    06 Aug 2015
    Other versions
    		 v1 (removed from public view)
    Version creation reason

    Trial information

    		 Close Top of page
    Trial identification
    Sponsor protocol code
    TMC207TBC1002
    Additional study identifiers
    ISRCTN number
    		 -
    US NCT number
    		 NCT01803373
    WHO universal trial number (UTN)
    		 -
    Sponsors
    Sponsor organisation name
    Janssen-Cilag International NV
    Sponsor organisation address
    Archimedesweg 29, Leiden, Netherlands, 233CM
    Public contact
    Clinical Registry Group, Janssen-Cilag International NV, +31 71524166, clinicaltrialsEU@its.jnj.com
    Scientific contact
    Clinical Registry Group, Janssen-Cilag International NV, +31 71524166, clinicaltrialsEU@its.jnj.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    		 EMEA-000912-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
    26 Aug 2013
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    26 Aug 2013
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    The primary objective is to assess the relative bioavailability of TMC207 after single-dose administration of 100 mg of TMC207 as water dispersible tablets or granules using a 100-mg tablet formulation as the reference, with and without food.
    Protection of trial subjects
    The safety assessments include clinical laboratory results (Haematology, Serum chemistry, Urinalysis) physical examination, electrocardiogram (ECG), vital signs, alcohol breath test and adverse events were monitored throughout the study.
    Background therapy
    		 -
    Evidence for comparator
    		 -
    Actual start date of recruitment
    16 Apr 2013
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    Netherlands: 36
    Worldwide total number of subjects
    36
    EEA total number of subjects
    36
    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)
    36
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    		 -

    Pre-assignment
    Screening details
    		 A total of 86 participants were Screened, among those 36 participants were randomized and received at least 1 dose of study drug.

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

    Arms
    Are arms mutually exclusive
    Yes

    Arm title
    		 Panel 1
    Arm description
    		 Participants administered with treatment F001, G003 and G004 in six sequences with standard breakfast.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    F001
    Other name
    TMC207
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 1x100 mg tablet orally with approximately 240 mL of water once daily.

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    G003
    Other name
    TMC207
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 5 X 20 mg Water dispersible tablets as oral suspension once daily.

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    G004
    Other name
    TMC207
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 5 g of granules containing 20mg/g as oral solution once daily.

    Arm title
    		 Panel 3
    Arm description
    		 Participants administered with treatment F001, G003 and G004 in six sequences after 10 hours overnight fast.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    F001
    Other name
    TMC207
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 1x100 mg tablet orally with approximately 240 mL of water once daily.

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    G003
    Other name
    TMC207
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 5 X 20 mg Water dispersible tablets as oral suspension once daily.

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    G004
    Other name
    TMC207
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 5 g of granules containing 20mg/g as oral solution once daily.

    Arm title
    		 Panel 2
    Arm description
    		 Participants were administered with treatment F001, G003 and G004 in six sequences with standard regular fat yog-hurt.
    Arm type
    		 Experimental

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    F001
    Other name
    TMC207
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 1x100 mg tablet orally with approximately 240 mL of water once daily.

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    G003
    Other name
    TMC207
    Pharmaceutical forms
    Dispersible tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 5 X 20 mg Water dispersible tablets as oral suspension once daily.

    Investigational medicinal product name
    Bedaquiline fumarate
    Investigational medicinal product code
    G004
    Other name
    TMC207
    Pharmaceutical forms
    Granules
    Routes of administration
    Oral use
    Dosage and administration details
    Participants administered with Bedaquiline (TMC207) 100 mg as 5 g of granules containing 20mg/g as oral solution once daily.

    Number of subjects in period 1
    		Panel 1 Panel 3 Panel 2
    Started
    12
    12
    12
    Completed
    11
    9
    12
    Not completed
    1
    3
    0
         Consent withdrawn by subject
    1
    1
    -
         Lost to follow-up
    -
    2
    -

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Panel 1
    Reporting group description
    		 Participants administered with treatment F001, G003 and G004 in six sequences with standard breakfast.

    Reporting group title
    Panel 3
    Reporting group description
    		 Participants administered with treatment F001, G003 and G004 in six sequences after 10 hours overnight fast.

    Reporting group title
    Panel 2
    Reporting group description
    		 Participants were administered with treatment F001, G003 and G004 in six sequences with standard regular fat yog-hurt.

    Reporting group values
    		 Panel 1 Panel 3 Panel 2 Total
    Number of subjects
    		 12 12 12 36
    Title for AgeCategorical
    Units: subjects
        Children (2-11 years)
    		 0 0 0 0
        Adolescents (12-17 years)
    		 0 0 0 0
        Adults (18-64 years)
    		 12 12 12 36
        From 65 to 84 years
    		 0 0 0 0
        85 years and over
    		 0 0 0 0
    Title for AgeContinuous
    Units: years
        arithmetic mean (standard deviation)
    		 36.8 ± 10.24 32.8 ± 12.4 32.5 ± 13.63 -
    Title for Gender
    Units: subjects
        Female
    		 0 1 0 1
        Male
    		 12 11 12 35

    End points

    		 Close Top of page
    End points reporting groups
    Reporting group title
    Panel 1
    Reporting group description
    		 Participants administered with treatment F001, G003 and G004 in six sequences with standard breakfast.

    Reporting group title
    Panel 3
    Reporting group description
    		 Participants administered with treatment F001, G003 and G004 in six sequences after 10 hours overnight fast.

    Reporting group title
    Panel 2
    Reporting group description
    		 Participants were administered with treatment F001, G003 and G004 in six sequences with standard regular fat yog-hurt.

    Subject analysis set title
    Panel 1: Standard Breakfast-Tablet (F001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with Tablet (FOO1) in panel 1 with standardized breakfast.

    Subject analysis set title
    Panel 1: Standard Breakfast-Water Dispersible Tablets (G003)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with Water Dispersible Tablets (G003) in panel 1 with standardized breakfast.

    Subject analysis set title
    Panel 1: Standard Breakfast-Granules (G004)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with Water Dispersible Granules (G004) in panel 1 with standardized breakfast.

    Subject analysis set title
    Panel 2: Yoghurt-Tablet (F001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with tablet (F001) in panel 2 with Standardized Regular-Fat Yoghurt.

    Subject analysis set title
    Panel 2: Yoghurt-Water Dispersible Tablets (G003)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with water Dispersible Tablets (G003) in panel 2 with Standardized Regular-Fat Yoghurt.

    Subject analysis set title
    Panel 2: Yoghurt-Granules (G004)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with granules (G004) in panel 2 with Standardized Regular-Fat Yoghurt.

    Subject analysis set title
    Panel 3: Fasted-Tablet (F001)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with tablet (F001) in panel 3 with fasted condition.

    Subject analysis set title
    Panel 3: Fasted-Water Dispersible Tablets (G003)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with Water Dispersible Tablets (G003) in panel 3 with fasted conditions.

    Subject analysis set title
    Panel 3: Fasted-Granules (G004)
    Subject analysis set type
    		 Per protocol
    Subject analysis set description
    Participants were administered with granules (G004) in panel 3 with fasted conditions.

    Subject analysis set title
    Tablet 100 milligram (mg)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants were administerd with 100 mg tablet orally once in a day.

    Subject analysis set title
    Water Dispersible Tablets 100 milligram (mg)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants were administerd with 5x20 mg water dispersible tablet orally once in a day.

    Subject analysis set title
    Granules 5 x 20 milligram (mg)
    Subject analysis set type
    		 Intention-to-treat
    Subject analysis set description
    Participants were administerd with 5x20 mg water dispersible tablet orally once in a day.

    Primary: Maximum Observed Plasma Concentration (Cmax) of Bedaquiline

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Bedaquiline
    End point description
    The Cmax is the maximum amount of plasma analyte concentration observed in blood sample.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 9, 12, 24, 48 and 72 hours postdose
    End point values
    		 Panel 1: Standard Breakfast-Tablet (F001) Panel 1: Standard Breakfast-Water Dispersible Tablets (G003) Panel 1: Standard Breakfast-Granules (G004) Panel 2: Yoghurt-Tablet (F001) Panel 2: Yoghurt-Water Dispersible Tablets (G003) Panel 2: Yoghurt-Granules (G004) Panel 3: Fasted-Tablet (F001) Panel 3: Fasted-Water Dispersible Tablets (G003) Panel 3: Fasted-Granules (G004)
    Number of subjects analysed
    12
    11
    12
    12
    12
    12
    10
    10
    12
    Units: nanogram per millilitre (ng/mL)
        arithmetic mean (standard deviation)
    939 ± 311
    1005 ± 380
    910 ± 339
    605 ± 175
    679 ± 211
    743 ± 279
    367 ± 168
    371 ± 142
    398 ± 148
    Statistical analysis title
    		 Panel 1: F001 vs. G003
    Comparison groups
    Panel 1: Standard Breakfast-Tablet (F001) v Panel 1: Standard Breakfast-Water Dispersible Tablets (G003)
    Number of subjects included in analysis
    23
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Cmax LSmeans Ratio
    Point estimate
    105.42
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 97.07
         upper limit
    		 114.49
    Statistical analysis title
    		 Panel 1: F001 vs. G004
    Comparison groups
    Panel 1: Standard Breakfast-Tablet (F001) v Panel 1: Standard Breakfast-Granules (G004)
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Cmax LSmeans Ratio
    Point estimate
    95.72
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 88.39
         upper limit
    		 103.65
    Statistical analysis title
    		 Panel 2: F001 vs. G003
    Comparison groups
    Panel 2: Yoghurt-Tablet (F001) v Panel 2: Yoghurt-Water Dispersible Tablets (G003)
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Cmax LSmeans Ratio
    Point estimate
    111.93
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 100.23
         upper limit
    		 124.99
    Statistical analysis title
    		 Panel 2: F001 vs. G004
    Comparison groups
    Panel 2: Yoghurt-Granules (G004) v Panel 2: Yoghurt-Tablet (F001)
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Cmax LSmeans Ratio
    Point estimate
    119.74
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 107.22
         upper limit
    		 133.71
    Statistical analysis title
    		 Panel 3: F001 vs. G003
    Comparison groups
    Panel 3: Fasted-Tablet (F001) v Panel 3: Fasted-Water Dispersible Tablets (G003)
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Cmax LSmeans Ratio
    Point estimate
    103.5
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 84.01
         upper limit
    		 127.52
    Statistical analysis title
    		 Panel 3: F001 vs. G004
    Comparison groups
    Panel 3: Fasted-Tablet (F001) v Panel 3: Fasted-Granules (G004)
    Number of subjects included in analysis
    22
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 Cmax LSmeans Ratio
    Point estimate
    107.48
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 87.17
         upper limit
    		 132.52

    Primary: Area Under the Plasma Concentration Time Curve From Time of Administration up to 72 Hours Post Dosing (AUC[0-72]) of Bedaquiline

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    End point title
    		 Area Under the Plasma Concentration Time Curve From Time of Administration up to 72 Hours Post Dosing (AUC[0-72]) of Bedaquiline
    End point description
    AUC (0-72)is defined as Area Under Curve from time of administration of to 72 hours post dosing, and it is calculated by linear trapezoidal summation.
    End point type
    Primary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 9, 12, 24, 48 and 72 hours postdose
    End point values
    		 Panel 1: Standard Breakfast-Tablet (F001) Panel 1: Standard Breakfast-Water Dispersible Tablets (G003) Panel 1: Standard Breakfast-Granules (G004) Panel 2: Yoghurt-Tablet (F001) Panel 2: Yoghurt-Water Dispersible Tablets (G003) Panel 2: Yoghurt-Granules (G004) Panel 3: Fasted-Tablet (F001) Panel 3: Fasted-Water Dispersible Tablets (G003) Panel 3: Fasted-Granules (G004)
    Number of subjects analysed
    12
    11
    12
    12
    12
    12
    10
    10
    12
    Units: AUC nanogram.hours/millilitre (ng.h/mL)
        arithmetic mean (standard deviation)
    13133 ± 4343
    13316 ± 5188
    12865 ± 4276
    9535 ± 1580
    10854 ± 2355
    11431 ± 3211
    7308 ± 3665
    7249 ± 2459
    7394 ± 2154
    Statistical analysis title
    		 Panel 1: F001 vs. G003
    Comparison groups
    Panel 1: Standard Breakfast-Tablet (F001) v Panel 1: Standard Breakfast-Water Dispersible Tablets (G003)
    Number of subjects included in analysis
    23
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 AUC72h, ng.h/mL LSmeans Ratio
    Point estimate
    97.94
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 91.8
         upper limit
    		 104.5
    Statistical analysis title
    		 Panel 1: F001 vs. G004
    Comparison groups
    Panel 1: Standard Breakfast-Tablet (F001) v Panel 1: Standard Breakfast-Granules (G004)
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 AUC72h, ng.h/mL LSmeans Ratio
    Point estimate
    97.8
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 91.87
         upper limit
    		 104.1
    Statistical analysis title
    		 Panel 2: F001 vs. G003
    Comparison groups
    Panel 2: Yoghurt-Tablet (F001) v Panel 2: Yoghurt-Water Dispersible Tablets (G003)
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 AUC72h, ng.h/mL LSmeans Ratio
    Point estimate
    113.01
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 105.43
         upper limit
    		 121.14
    Statistical analysis title
    		 Panel 2: F001 vs. G004
    Comparison groups
    Panel 2: Yoghurt-Tablet (F001) v Panel 2: Yoghurt-Granules (G004)
    Number of subjects included in analysis
    24
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 AUC72h, ng.h/mL LSmeans Ratio
    Point estimate
    117.61
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 109.72
         upper limit
    		 126.07
    Statistical analysis title
    		 Panel 3: F001 vs. G003
    Comparison groups
    Panel 3: Fasted-Tablet (F001) v Panel 3: Fasted-Water Dispersible Tablets (G003)
    Number of subjects included in analysis
    20
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 AUC72h, ng.h/mL LSmeans Ratio
    Point estimate
    104.66
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 86.94
         upper limit
    		 125.99
    Statistical analysis title
    		 Panel 3: F001 vs. G004
    Comparison groups
    Panel 3: Fasted-Tablet (F001) v Panel 3: Fasted-Granules (G004)
    Number of subjects included in analysis
    22
    Analysis specification
    Post-hoc
    Analysis type
    		 equivalence
    Method
    Parameter type
    		 AUC72h, ng.h/mL LSmeans Ratio
    Point estimate
    106.61
    Confidence interval
         level
    		 90%
         sides
    2-sided
         lower limit
    		 88.51
         upper limit
    		 128.4

    Secondary: Maximum Observed Plasma Concentration (Cmax) of Metabolite M2

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    End point title
    		 Maximum Observed Plasma Concentration (Cmax) of Metabolite M2
    End point description
    The Cmax is the maximum amount of plasma analyte concentration observed in blood sample.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 9, 12, 24, 48 and 72 hours postdose
    End point values
    		 Panel 1: Standard Breakfast-Tablet (F001) Panel 1: Standard Breakfast-Water Dispersible Tablets (G003) Panel 1: Standard Breakfast-Granules (G004) Panel 2: Yoghurt-Tablet (F001) Panel 2: Yoghurt-Water Dispersible Tablets (G003) Panel 2: Yoghurt-Granules (G004) Panel 3: Fasted-Tablet (F001) Panel 3: Fasted-Water Dispersible Tablets (G003) Panel 3: Fasted-Granules (G004)
    Number of subjects analysed
    12
    11
    12
    12
    12
    12
    10
    10
    12
    Units: nanogram per millilitre (ng/mL)
        arithmetic mean (standard deviation)
    17.4 ± 4.31
    15 ± 4.52
    16.8 ± 5.38
    15.6 ± 4
    16.7 ± 4.09
    16.3 ± 2.9
    13.6 ± 7.47
    12.6 ± 3.61
    13.7 ± 3.95
    No statistical analyses for this end point

    Secondary: Area Under the Plasma Concentration Time Curve From Time of Administration up to 72 Hours Post Dosing (AUC[0-72]) of Metabolite M2

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    End point title
    		 Area Under the Plasma Concentration Time Curve From Time of Administration up to 72 Hours Post Dosing (AUC[0-72]) of Metabolite M2
    End point description
    AUC (0-72)is defined as Area Under Curve from time of administration of to 72 hours post dosing, and it is calculated by linear trapezoidal summation.
    End point type
    Secondary
    End point timeframe
    Predose, 1, 2, 3, 4, 5, 6, 8, 9, 12, 24, 48 and 72 hours postdose
    End point values
    		 Panel 1: Standard Breakfast-Tablet (F001) Panel 1: Standard Breakfast-Water Dispersible Tablets (G003) Panel 1: Standard Breakfast-Granules (G004) Panel 2: Yoghurt-Tablet (F001) Panel 2: Yoghurt-Water Dispersible Tablets (G003) Panel 2: Yoghurt-Granules (G004) Panel 3: Fasted-Tablet (F001) Panel 3: Fasted-Water Dispersible Tablets (G003) Panel 3: Fasted-Granules (G004)
    Number of subjects analysed
    12
    11
    12
    12
    12
    12
    10
    10
    12
    Units: AUC nanogram.hours/millilitre (ng.h/mL)
        arithmetic mean (standard deviation)
    889 ± 248
    851 ± 262
    901 ± 294
    830 ± 240
    900 ± 237
    876 ± 199
    679 ± 297
    662 ± 171
    716 ± 193
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to 72 hours
    Assessment type
    		 Non-systematic
    Dictionary used for adverse event reporting
    Dictionary name
    		 MedDRA
    Dictionary version
    16
    Reporting groups
    Reporting group title
    F001
    Reporting group description
    		 Participants were administered with F001 100 mg oral tablet orally once a day.

    Reporting group title
    G003
    Reporting group description
    		 Participants were administered with G003 20 mg water dispersible tablet orally once in a day.

    Reporting group title
    G004
    Reporting group description
    		 Participants were administered with G004 5 mg (20 mg/g) oral granules once in a day

    Serious adverse events
    		 F001 G003 G004
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 34 (0.00%)
    0 / 33 (0.00%)
    0 / 36 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    		 F001 G003 G004
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    6 / 34 (17.65%)
    3 / 33 (9.09%)
    6 / 36 (16.67%)
    Nervous system disorders
    Headache
    alternative assessment type: Systematic
         subjects affected / exposed
    5 / 34 (14.71%)
    2 / 33 (6.06%)
    4 / 36 (11.11%)
         occurrences all number
    5
    2
    4
    Infections and infestations
    Nasopharyngitis
    alternative assessment type: Systematic
         subjects affected / exposed
    1 / 34 (2.94%)
    1 / 33 (3.03%)
    2 / 36 (5.56%)
         occurrences all number
    1
    1
    2

    More information

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    Substantial protocol amendments (globally)
    Were there any global substantial amendments to the protocol? Yes
    Date
    Amendment
    19 Mar 2013
    The contraception inclusion criteria was adjusted to reflect 6 months of precautions (instead of 3 months) for men, inclusion criteria for women were adjusted to only include women that are >2 years postmenopausal, surgically sterile women were no longer allowed to enter the study, and some minor editorial changes.

    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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