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
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EudraCT number |
2010-021156-26 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
06 Aug 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
28 Jun 2016
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First version publication date |
07 Aug 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
VX10-950-022
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
- | ||
WHO universal trial number (UTN) |
- | ||
Sponsors
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Sponsor organisation name |
Vertex Pharmaceuticals Incorporated
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Sponsor organisation address |
50 Northern Avenue, Boston, MA, United States, 02210-1862
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Public contact |
Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617-341-6777, medicalinfo@vrtx.com
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Scientific contact |
Medical Monitor, Vertex Pharmaceuticals Incorporated, +1 617-341-6777, medicalinfo@vrtx.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
Yes
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EMA paediatric investigation plan number(s) |
EMEA-000196-PIP01-08 | ||
Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
15 Oct 2010
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Is this the analysis of the primary completion data? |
No
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Global end of trial reached? |
Yes
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Global end of trial date |
06 Aug 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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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.
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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).
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
21 Jun 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
United States: 18
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Worldwide total number of subjects |
18
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
0
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Adolescents (12-17 years) |
0
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Adults (18-64 years) |
18
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
- | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Pre-assignment
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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
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Period 1 title |
Overall Study (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Allocation method |
Randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Arms
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Are arms mutually exclusive |
Yes
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Arm title
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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
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Investigational medicinal product code |
VX-950
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Arm title
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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
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Investigational medicinal product code |
VX-950
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Arm title
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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
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Investigational medicinal product code |
VX-950
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Arm title
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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
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Investigational medicinal product code |
VX-950
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Arm title
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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
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Investigational medicinal product code |
VX-950
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Arm title
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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
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Investigational medicinal product code |
VX-950
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Other name |
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Pharmaceutical forms |
Tablet
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Routes of administration |
Oral use
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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.
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Baseline characteristics reporting groups
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Reporting group title |
Dosing Sequence 1 R/TF/T
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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
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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
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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
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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
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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
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Reporting group description |
Subject received the dose of drug in the sequence of R/T/TF in each period. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Dosing Sequence 1 R/TF/T
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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
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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
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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
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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
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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
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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
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects who received Treatment R in any treatment period.
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Subject analysis set title |
Treatment T
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects who received Treatment T in any treatment period.
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Subject analysis set title |
Treatment TF
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Subject analysis set type |
Sub-group analysis | ||
Subject analysis set description |
Subjects who received Treatment TF in any treatment period.
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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.
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End point type |
Primary
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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
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Statistical analysis title |
AUC[0-infinity] of Telaprevir | ||||||||||||
Comparison groups |
Treatment T v Treatment R
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Number of subjects included in analysis |
33
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Geometric Least Squares Mean ratio | ||||||||||||
Point estimate |
1.12
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
0.956 | ||||||||||||
upper limit |
1.31 |
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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.
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End point type |
Primary
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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
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Statistical analysis title |
AUC(0-infinity) of Telaprevir – Food Effect | ||||||||||||
Comparison groups |
Treatment TF v Treatment T
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Geometric Least Squares Mean ratio | ||||||||||||
Point estimate |
0.356
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
0.301 | ||||||||||||
upper limit |
0.421 |
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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.
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End point type |
Primary
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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
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Statistical analysis title |
AUC[0-last] of Telaprevir | ||||||||||||
Comparison groups |
Treatment T v Treatment R
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Number of subjects included in analysis |
33
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Geometric Least Squares Mean ratio | ||||||||||||
Point estimate |
1.15
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
0.993 | ||||||||||||
upper limit |
1.32 |
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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.
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End point type |
Primary
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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
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Statistical analysis title |
AUC(0-last) of Telaprevir – Food Effect | ||||||||||||
Comparison groups |
Treatment TF v Treatment T
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Number of subjects included in analysis |
31
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Analysis specification |
Pre-specified
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Analysis type |
superiority | ||||||||||||
Method |
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Parameter type |
Geometric Least Squares Mean ratio | ||||||||||||
Point estimate |
0.339
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Confidence interval |
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level |
90% | ||||||||||||
sides |
2-sided
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lower limit |
0.291 | ||||||||||||
upper limit |
0.396 |
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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.
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End point type |
Primary
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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
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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 |
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
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 |
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||
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
|
||||||||||||
|
|||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||
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)
|
||||||||||||||||||||||||
|
|||||||||||||||||||||||||
No statistical analyses for this end point |
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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) | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Frequency threshold for reporting non-serious adverse events: 0% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
|
|||
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 |