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    Clinical Trial Results:
    A Phase 1, Randomized, Open-label, Single-Dose, Crossover, Relative Bioavailability, and Food-Effect Study of a Pediatric Chewable Tablet Formulation Relative to a 375-mg Core Tablet Formulation of Telaprevir in Healthy Adult Subjects

    Summary
    EudraCT number
    2010-021156-26
    Trial protocol
    Outside EU/EEA  
    Global end of trial date
    06 Aug 2010

    Results information
    Results version number
    v1(current)
    This version publication date
    28 Jun 2016
    First version publication date
    07 Aug 2015
    Other versions

    Trial information

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    Trial identification
    Sponsor protocol code
    VX10-950-022
    Additional study identifiers
    ISRCTN number
    -
    US NCT number
    -
    WHO universal trial number (UTN)
    -
    Sponsors
    Sponsor organisation name
    Vertex Pharmaceuticals Incorporated
    Sponsor organisation address
    50 Northern Avenue, Boston, MA, United States, 02210-1862
    Public contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617-341-6777, medicalinfo@vrtx.com
    Scientific contact
    Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617-341-6777, medicalinfo@vrtx.com
    Paediatric regulatory details
    Is trial part of an agreed paediatric investigation plan (PIP)
    Yes
    EMA paediatric investigation plan number(s)
    EMEA-000196-PIP01-08
    Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?
    No
    Results analysis stage
    Analysis stage
    Final
    Date of interim/final analysis
    15 Oct 2010
    Is this the analysis of the primary completion data?
    No
    Global end of trial reached?
    Yes
    Global end of trial date
    06 Aug 2010
    Was the trial ended prematurely?
    No
    General information about the trial
    Main objective of the trial
    To determine the bioavailability of telaprevir administered as a pediatric chewable tablet formulation relative to a 375-milligram (mg) core tablet formulation in the fed state; To evaluate the effect of food on the pharmacokinetics (PK) of telaprevir administered as a pediatric chewable tablet formulation.
    Protection of trial subjects
    The study was conducted in accordance with the ethical principles stated in the Declaration of Helsinki and the International Conference on Harmonization (ICH) Guideline for Good Clinical Practice (GCP).
    Background therapy
    -
    Evidence for comparator
    -
    Actual start date of recruitment
    21 Jun 2010
    Long term follow-up planned
    No
    Independent data monitoring committee (IDMC) involvement?
    No
    Population of trial subjects
    Number of subjects enrolled per country
    Country: Number of subjects enrolled
    United States: 18
    Worldwide total number of subjects
    18
    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)
    18
    From 65 to 84 years
    0
    85 years and over
    0

    Subject disposition

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    Recruitment
    Recruitment details
    -

    Pre-assignment
    Screening details
    At total of 18 subjects were enrolled and randomized in the study. All 18 subjects received at least 1 dose of telaprevir in either the core tablet or pediatric formulation. The numbers reported in subject disposition are in regard to study. Started = Randomized, Completed = Completed Study, Not completed = Not completed 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
    Dosing Sequence 1 R/TF/T
    Arm description
    R = reference formulation (375 milligram (mg) core tablet formulation of telaprevir administered in the fed state), T = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fed state), and TF = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fasted state). Subject received the dose of drug in the sequence of R/TF/T in each period.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject receive telaprevir as 375 mg-core formulation or 250 mg pediatric chewable tablet formulation either in fasted or fed state in each period.

    Arm title
    Dosing Sequence 2 T/R/TF
    Arm description
    Subject received the dose of drug in the sequence of T/R/TF in each period.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject receive telaprevir as 375 mg-core formulation or 250 mg pediatric chewable tablet formulation either in fasted or fed state in each period.

    Arm title
    Dosing Sequence 3 TF/T/R
    Arm description
    Subject received the dose of drug in the sequence of TF/T/R in each period.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject receive telaprevir as 375 mg-core formulation or 250 mg pediatric chewable tablet formulation either in fasted or fed state in each period.

    Arm title
    Dosing Sequence 4 T/TF/R
    Arm description
    Subject received the dose of drug in the sequence of T/TF/R in each period.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject receive telaprevir as 375 mg-core formulation or 250 mg pediatric chewable tablet formulation either in fasted or fed state in each period.

    Arm title
    Dosing Sequence 5 TF/R/T
    Arm description
    Subject received the dose of drug in the sequence of TF/R/T in each period.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject receive telaprevir as 375 mg-core formulation or 250 mg pediatric chewable tablet formulation either in fasted or fed state in each period.

    Arm title
    Dosing Sequence 6 R/T/TF
    Arm description
    Subject received the dose of drug in the sequence of R/T/TF in each period.
    Arm type
    Experimental

    Investigational medicinal product name
    Telaprevir
    Investigational medicinal product code
    VX-950
    Other name
    Pharmaceutical forms
    Tablet
    Routes of administration
    Oral use
    Dosage and administration details
    Subject receive telaprevir as 375 mg-core formulation or 250 mg pediatric chewable tablet formulation either in fasted or fed state in each period.

    Number of subjects in period 1
    Dosing Sequence 1 R/TF/T Dosing Sequence 2 T/R/TF Dosing Sequence 3 TF/T/R Dosing Sequence 4 T/TF/R Dosing Sequence 5 TF/R/T Dosing Sequence 6 R/T/TF
    Started
    3
    3
    3
    3
    3
    3
    Completed
    1
    3
    2
    2
    3
    2
    Not completed
    2
    0
    1
    1
    0
    1
         Adverse event
    1
    -
    -
    -
    -
    -
         Consent withdrawn by subject
    -
    -
    -
    1
    -
    -
         Unspecified
    1
    -
    -
    -
    -
    -
         Lost to follow-up
    -
    -
    1
    -
    -
    1

    Baseline characteristics

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    Baseline characteristics reporting groups
    Reporting group title
    Dosing Sequence 1 R/TF/T
    Reporting group description
    R = reference formulation (375 milligram (mg) core tablet formulation of telaprevir administered in the fed state), T = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fed state), and TF = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fasted state). Subject received the dose of drug in the sequence of R/TF/T in each period.

    Reporting group title
    Dosing Sequence 2 T/R/TF
    Reporting group description
    Subject received the dose of drug in the sequence of T/R/TF in each period.

    Reporting group title
    Dosing Sequence 3 TF/T/R
    Reporting group description
    Subject received the dose of drug in the sequence of TF/T/R in each period.

    Reporting group title
    Dosing Sequence 4 T/TF/R
    Reporting group description
    Subject received the dose of drug in the sequence of T/TF/R in each period.

    Reporting group title
    Dosing Sequence 5 TF/R/T
    Reporting group description
    Subject received the dose of drug in the sequence of TF/R/T in each period.

    Reporting group title
    Dosing Sequence 6 R/T/TF
    Reporting group description
    Subject received the dose of drug in the sequence of R/T/TF in each period.

    Reporting group values
    Dosing Sequence 1 R/TF/T Dosing Sequence 2 T/R/TF Dosing Sequence 3 TF/T/R Dosing Sequence 4 T/TF/R Dosing Sequence 5 TF/R/T Dosing Sequence 6 R/T/TF Total
    Number of subjects
    3 3 3 3 3 3 18
    Age categorical
    Units: Subjects
    Age continuous
    Units: years
        arithmetic mean (standard deviation)
    34.3 ± 10.69 26 ± 3 46 ± 8 35.7 ± 4.04 35 ± 21.66 38.7 ± 7.51 -
    Gender categorical
    Units: Subjects
        Female
    0 0 0 0 0 2 2
        Male
    3 3 3 3 3 1 16

    End points

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    End points reporting groups
    Reporting group title
    Dosing Sequence 1 R/TF/T
    Reporting group description
    R = reference formulation (375 milligram (mg) core tablet formulation of telaprevir administered in the fed state), T = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fed state), and TF = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fasted state). Subject received the dose of drug in the sequence of R/TF/T in each period.

    Reporting group title
    Dosing Sequence 2 T/R/TF
    Reporting group description
    Subject received the dose of drug in the sequence of T/R/TF in each period.

    Reporting group title
    Dosing Sequence 3 TF/T/R
    Reporting group description
    Subject received the dose of drug in the sequence of TF/T/R in each period.

    Reporting group title
    Dosing Sequence 4 T/TF/R
    Reporting group description
    Subject received the dose of drug in the sequence of T/TF/R in each period.

    Reporting group title
    Dosing Sequence 5 TF/R/T
    Reporting group description
    Subject received the dose of drug in the sequence of TF/R/T in each period.

    Reporting group title
    Dosing Sequence 6 R/T/TF
    Reporting group description
    Subject received the dose of drug in the sequence of R/T/TF in each period.

    Subject analysis set title
    Treatment R
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who received Treatment R in any treatment period.

    Subject analysis set title
    Treatment T
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who received Treatment T in any treatment period.

    Subject analysis set title
    Treatment TF
    Subject analysis set type
    Sub-group analysis
    Subject analysis set description
    Subjects who received Treatment TF in any treatment period.

    Primary: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) of Telaprevir

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    End point title
    Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinity (AUC[0-infinity]) of Telaprevir
    End point description
    The AUC(0-infinity) is the area under the plasma concentration-time curve from time zero extrapolated to infinite time, calculated as the sum of AUC(last) and C(last)/lambda(z); wherein AUC(last) is area under the plasma concentration-time curve from time zero to last quantifiable time, C(last) is the last observed quantifiable concentration, and lambda(z) is elimination rate constant. Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment R Treatment T
    Number of subjects analysed
    17
    16
    Units: nanogram*hour per milliliter (ng*hr/mL)
        arithmetic mean (standard deviation)
    13191.97 ± 6689.84
    14667.41 ± 7098.81
    Statistical analysis title
    AUC[0-infinity] of Telaprevir
    Comparison groups
    Treatment T v Treatment R
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Geometric Least Squares Mean ratio
    Point estimate
    1.12
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.956
         upper limit
    1.31

    Primary: AUC(0-infinity) of Telaprevir – Food Effect

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    End point title
    AUC(0-infinity) of Telaprevir – Food Effect
    End point description
    AUC(0-infinity) is defined in first primary endpoint. Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment T Treatment TF
    Number of subjects analysed
    16
    15
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    14667.41 ± 7098.81
    5644.7 ± 1324.28
    Statistical analysis title
    AUC(0-infinity) of Telaprevir – Food Effect
    Comparison groups
    Treatment TF v Treatment T
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Geometric Least Squares Mean ratio
    Point estimate
    0.356
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.301
         upper limit
    0.421

    Primary: Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Telaprevir

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    End point title
    Area Under the Plasma Concentration-Time Curve From Time 0 to Time of the Last Observed Quantifiable Concentration (AUC[0-last]) of Telaprevir
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment R Treatment T
    Number of subjects analysed
    17
    16
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    12486.45 ± 6242.3
    14239.8 ± 6802.81
    Statistical analysis title
    AUC[0-last] of Telaprevir
    Comparison groups
    Treatment T v Treatment R
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Geometric Least Squares Mean ratio
    Point estimate
    1.15
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.993
         upper limit
    1.32

    Primary: AUC(0-last) of Telaprevir – Food Effect

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    End point title
    AUC(0-last) of Telaprevir – Food Effect
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment T Treatment TF
    Number of subjects analysed
    16
    15
    Units: ng*hr/mL
        arithmetic mean (standard deviation)
    14239.8 ± 6802.81
    4903.67 ± 1814.37
    Statistical analysis title
    AUC(0-last) of Telaprevir – Food Effect
    Comparison groups
    Treatment TF v Treatment T
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Geometric Least Squares Mean ratio
    Point estimate
    0.339
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.291
         upper limit
    0.396

    Primary: Maximum Observed Plasma Concentration (Cmax) of Telaprevir

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    End point title
    Maximum Observed Plasma Concentration (Cmax) of Telaprevir
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment R Treatment T
    Number of subjects analysed
    17
    16
    Units: nanogram per milliliter (ng/mL)
        arithmetic mean (standard deviation)
    2295.71 ± 902.5
    2522.13 ± 1019.09
    Statistical analysis title
    (Cmax) of Telaprevir
    Comparison groups
    Treatment T v Treatment R
    Number of subjects included in analysis
    33
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Geometric Least Squares Mean ratio
    Point estimate
    1.08
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.881
         upper limit
    1.33

    Primary: Cmax of Telaprevir – Food Effect

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    End point title
    Cmax of Telaprevir – Food Effect
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Primary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment T Treatment TF
    Number of subjects analysed
    16
    15
    Units: ng/mL
        arithmetic mean (standard deviation)
    2522.13 ± 1019.09
    608.22 ± 270.98
    Statistical analysis title
    Cmax of Telaprevir – Food Effect
    Comparison groups
    Treatment TF v Treatment T
    Number of subjects included in analysis
    31
    Analysis specification
    Pre-specified
    Analysis type
    superiority
    Method
    Parameter type
    Geometric Least Squares Mean ratio
    Point estimate
    0.221
    Confidence interval
         level
    90%
         sides
    2-sided
         lower limit
    0.177
         upper limit
    0.274

    Secondary: Time to Reach Cmax (tmax) of Telaprevir

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    End point title
    Time to Reach Cmax (tmax) of Telaprevir
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment R Treatment T
    Number of subjects analysed
    17
    16
    Units: hours
        median (full range (min-max))
    5 (3.5 to 12)
    5 (2.5 to 6.05)
    No statistical analyses for this end point

    Secondary: Tmax of Telaprevir – Food Effect

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    End point title
    Tmax of Telaprevir – Food Effect
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment T Treatment TF
    Number of subjects analysed
    16
    15
    Units: hours
        median (full range (min-max))
    5 (2.5 to 6.05)
    4 (1.5 to 6)
    No statistical analyses for this end point

    Secondary: Terminal Elimination Half-Life (t1/2) of Telaprevir

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    End point title
    Terminal Elimination Half-Life (t1/2) of Telaprevir
    End point description
    The t1/2 is the time measured for the plasma concentration to decrease by one-half to its original concentration. It is associated with the terminal slope of the semi logarithmic drug concentration-time curve, and is calculated as 0.693/lambda(z). Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment R Treatment T
    Number of subjects analysed
    17
    16
    Units: hours
        arithmetic mean (standard deviation)
    3.98 ± 0.87
    3.91 ± 1.19
    No statistical analyses for this end point

    Secondary: t1/2 of Telaprevir – Food Effect

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    End point title
    t1/2 of Telaprevir – Food Effect
    End point description
    Analysis was performed on PK analysis set included all subjects who had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Predose, 0.25, 0.5, 0.75, 1, 1.5, 2, 2.5, 3, 3.5, 4, 5, 6, 8, 10, 12, 16 and 24 hours postdose on Day 1 of each period
    End point values
    Treatment T Treatment TF
    Number of subjects analysed
    16
    15
    Units: hours
        arithmetic mean (standard deviation)
    3.91 ± 1.19
    4.46 ± 1.16
    No statistical analyses for this end point

    Secondary: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)

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    End point title
    Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
    End point description
    AE: any untoward medical occurrence in a subject during the study; the event does not necessarily have a causal relationship with the treatment. This includes any newly occurring event or previous condition that has increased in severity or frequency after the informed consent form is signed. SAE (subset of AE): medical event or condition, which falls into any of the following categories, regardless of its relationship to the study drug: death, life threatening adverse experience, in-patient hospitalization/prolongation of hospitalization, persistent/significant disability or incapacity, congenital anomaly/birth defect, important medical event. Analysis was performed on safety set included all subjects who had received at least 1 dose of study drug.
    End point type
    Secondary
    End point timeframe
    Up to Safety Follow-up (Day 28)
    End point values
    Treatment R Treatment T Treatment TF
    Number of subjects analysed
    17
    16
    15
    Units: subjects
    number (not applicable)
        Number of subjects with AEs
    2
    2
    2
        Number of subjects with SAEs
    0
    0
    0
    No statistical analyses for this end point

    Adverse events

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    Adverse events information
    Timeframe for reporting adverse events
    Up to Safety Follow-up (Day 28)
    Assessment type
    Systematic
    Dictionary used for adverse event reporting
    Dictionary name
    MedDRA
    Dictionary version
    13
    Reporting groups
    Reporting group title
    Treatment R
    Reporting group description
    R = reference formulation (375 milligram (mg) core tablet formulation of telaprevir administered in the fed state)

    Reporting group title
    Treatment T
    Reporting group description
    T = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fed state)

    Reporting group title
    Treatment TF
    Reporting group description
    TF = test formulation (250 mg pediatric chewable tablet telaprevir formulation administered in the fasted state)

    Serious adverse events
    Treatment R Treatment T Treatment TF
    Total subjects affected by serious adverse events
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         number of deaths (all causes)
    0
    0
    0
         number of deaths resulting from adverse events
    0
    0
    0
    Frequency threshold for reporting non-serious adverse events: 0%
    Non-serious adverse events
    Treatment R Treatment T Treatment TF
    Total subjects affected by non serious adverse events
         subjects affected / exposed
    2 / 17 (11.76%)
    2 / 16 (12.50%)
    2 / 15 (13.33%)
    Investigations
    BLOOD CREATINE PHOSPHOKINASE INCREASED
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Nervous system disorders
    HEADACHE
         subjects affected / exposed
    1 / 17 (5.88%)
    0 / 16 (0.00%)
    0 / 15 (0.00%)
         occurrences all number
    1
    0
    0
    Psychiatric disorders
    EUPHORIC MOOD
         subjects affected / exposed
    0 / 17 (0.00%)
    2 / 16 (12.50%)
    0 / 15 (0.00%)
         occurrences all number
    0
    2
    0
    Infections and infestations
    FOLLICULITIS
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1
    RHINITIS
         subjects affected / exposed
    0 / 17 (0.00%)
    0 / 16 (0.00%)
    1 / 15 (6.67%)
         occurrences all number
    0
    0
    1

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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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