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A Study to Assess the Anti-viral Activity, Safety, Tolerability and Pharmacokinetics of TMC435350 in Participants Infected With Hepatitis C-Virus (HCV)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00812331
Recruitment Status : Completed
First Posted : December 22, 2008
Results First Posted : July 28, 2014
Last Update Posted : July 28, 2014
Sponsor:
Information provided by (Responsible Party):
Tibotec Pharmaceuticals, Ireland

Study Type Interventional
Study Design Allocation: Non-Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Hepatitis C
Intervention Drug: TMC435
Enrollment 37
Recruitment Details A total of 37 participants from 3 countries were enrolled and started treatment in the study (17 participants in Belgium, 12 participants in Germany, and 8 participants in Thailand).
Pre-assignment Details A total of 48 participants were screened of which 11 participants were not treated with TMC435. A total of 37 participants received study medication.
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
Period Title: Overall Study
Started 6 8 8 7 8
Completed 5 8 8 7 8
Not Completed 1 0 0 0 0
Reason Not Completed
Adverse Event             1             0             0             0             0
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6 Total
Hide Arm/Group Description Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days Total of all reporting groups
Overall Number of Baseline Participants 6 8 8 7 8 37
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 6 participants 8 participants 8 participants 7 participants 8 participants 37 participants
43
(27 to 61)
42
(18 to 56)
47
(26 to 55)
65
(48 to 69)
49
(30 to 53)
48
(18 to 69)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 8 participants 7 participants 8 participants 37 participants
Female
4
  66.7%
3
  37.5%
5
  62.5%
4
  57.1%
2
  25.0%
18
  48.6%
Male
2
  33.3%
5
  62.5%
3
  37.5%
3
  42.9%
6
  75.0%
19
  51.4%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 8 participants 8 participants 7 participants 8 participants 37 participants
White 5 7 6 7 0 25
Asian 0 1 0 0 8 9
Black 1 0 2 0 0 3
1.Primary Outcome
Title Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
Hide Description The table below shows the mean changes from baseline in HCV RNA values (log10 IU/mL) per genotype on Day 3 and Day 7 during the TMC435 treatment period.
Time Frame Baseline, Day 3, and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Mean (Standard Error)
Unit of Measure: log10 IU/mL
Day 3 -2.02  (0.625) 0.16  (0.263) -3.43  (0.167) -2.71  (0.335) -3.57  (0.197)
Day 7 -2.46  (0.538) -0.13  (0.175) -3.66  (0.320) -2.43  (0.357) -4.40  (0.222)
2.Secondary Outcome
Title Number of Participants With a Decrease From Baseline of Greater Than or Equal to 2 log10 IU/mL in Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) During the TMC435 Treatment Period
Hide Description The table below shows the number of participants with a decrease from baseline of greater than or equal to 2 log10 IU/mL in HCV RNA during the 7-day TMC435 treatment period.
Time Frame Baseline, Day 3, Day 5 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population- all randomized subjects who received at least 1 dose of study medication (TMC435)
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Measure Type: Number
Unit of Measure: Participants
Day 3 3 0 8 6 8
Day 5 3 0 8 5 8
Day 7 3 0 8 5 8
3.Secondary Outcome
Title Number of Participants With Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels Below the Limit of Quantification (Less Than 25 IU/mL) and Limit of Detection (Less Than 25 IU/mL Undetectable) During the TMC435 Treatment Period
Hide Description The table below shows the number of participants with plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels below limit of quantification (less than 25 IU/mL) and limit of detection (less than 25 IU/mL undetectable), respectively, during the 7-day TMC435 treatment period.
Time Frame Baseline, Day 3, Day 5 and Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) Population - all randomized subjects who received at least 1 dose of study medication (TMC435)
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Measure Type: Number
Unit of Measure: Participants
Day 3 (less than 25 IU/mL) 0 0 0 0 0
Day 3 (less than 25 IU/mL undetectable) 0 0 0 0 0
Day 5 (less than 25 IU/mL) 0 0 2 0 1
Day 5 (less than 25 IU/mL undetectable) 0 0 1 0 0
Day 7 (less than 25 IU/mL) 0 0 3 0 1
Day 7 (less than 25 IU/mL undetectable) 0 0 0 0 0
4.Secondary Outcome
Title Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
Hide Description The table below shows the number of participants who experienced viral breakthrough (defined as an increase greater than 1 log10 IU/mL in plasma level of hepatitis C virus [HCV] ribonucleic acid [RNA] from the lowest level reached, or a HCV RNA level greater than 100 IU/mL in participants who previously had HCV RNA levels undetectable [less than 25 IU/mL undetectable] or not quantifiable [less than 25 IU/mL detectable]) during the 7-day TMC435 treatment period.
Time Frame During the 7-day of TMC435 treatment period
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Measure Type: Number
Unit of Measure: Participants
0 1 2 3 0
5.Secondary Outcome
Title Predose Plasma Concentration (C0h) of TMC435
Hide Description The table below shows the median predose plasma concentration (C0h) for all participants on Day 7 of the TMC435 treatment period.
Time Frame Predose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: ng/mL
3720
(164 to 8420)
1310
(492 to 4220)
6270
(1030 to 13100)
4650
(80.1 to 14500)
5440
(2280 to 11700)
6.Secondary Outcome
Title Minimum Plasma Concentration (Cmin) of TMC435
Hide Description The table below shows the median minimum plasma concentration (Cmin) for all participants on Day 7 of the TMC435 treatment period.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: ng/mL
3320
(156 to 8420)
1110
(463 to 3440)
5450
(1030 to 13100)
4230
(48.2 to 14300)
4960
(2080 to 10600)
7.Secondary Outcome
Title Maximum Plasma Concentration (Cmax) of TMC435
Hide Description The table below shows the median maximum plasma concentration (Cmax) for all participants by genotype of hepatitis C virus infection on Day 7 of the TMC435 treatment period.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: ng/mL
11250
(2360 to 18500)
6580
(2760 to 13200)
13500
(4530 to 26200)
13600
(215 to 24700)
14800
(3460 to 23000)
8.Secondary Outcome
Title Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
Hide Description The table below shows the median time in hours for all participants (by genotype of hepatitis C virus infection) to reach the maximum plasma concentration (tmax) of TMC435 following treatment.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: hours
4.01
(4.00 to 7.83)
6.025
(4.02 to 10.08)
6.04
(4.00 to 8.08)
6.00
(4.00 to 8.02)
6.00
(4.00 to 6.20)
9.Secondary Outcome
Title Average Steady-State Plasma Concentration (Css,av) of TMC435
Hide Description The table below shows the average steady-state TMC435 plasma concentration (Css,av) for all participants by genotype of hepatitis C virus infection on Day 7 during the TMC435 treatment period.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: ng/mL
7115
(1110 to 12870)
3081
(1410 to 7550)
8843
(2954 to 20340)
7850
(130.8 to 19660)
9354
(2602 to 16180)
10.Secondary Outcome
Title Fluctuation Index (FI) of TMC435
Hide Description The table below shows the percentage of fluctuation (FI) (defined as the variation between maximum and minimum TMC435 plasma concentrations at steady-state) of TMC435 on Day 7 for participants by genotype of hepatitis C virus infection.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: % fluctuation
130.2
(78.35 to 210.4)
149.4
(100.3 to 246.3)
95.38
(56.77 to 161.1)
93.12
(52.91 to 129.3)
88.16
(53.04 to 127.6)
11.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
Hide Description The table below shows the area under the plasma concentration-time curve from the time of administration up to 24 hours after dosing (AUC24h) of TMC435 on Day 7 for all participants by genotype of hepatitis C virus infection.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - as all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: ng*h/mL
170100
(26350 to 311000)
74670
(34500 to 199500)
212000
(70400 to 483000)
189000
(3084 to 457600)
227100
(63430 to 373500)
12.Secondary Outcome
Title Area Under the Plasma Concentration-time Curve From Time of Administration up to the Last Time Point With a Measurable Concentration After Dosing (AUClast) of TMC435
Hide Description The table below shows the area under the plasma concentration-time curve from time of administration up to the last time point with a measurable concentration after dosing (AUClast) on Day 7 for TMC435 by genotype of hepatitis C virus infection.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: ng*h/mL
268000
(31400 to 712600)
111500
(43680 to 272000)
365500
(99320 to 1179000)
360000
(3770 to 944400)
411100
(117500 to 798900)
13.Secondary Outcome
Title Elimination Rate Constant of TMC435
Hide Description In the table below, median values for the elimination rate constant (the rate at which a drug is removed from the body expressed per unit of time, e.g., fraction/hour) for TMC435 are shown for participants by genotype of hepatitis C virus infection.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: 1/hour
0.05042
(0.01776 to 0.08666)
0.06024
(0.04057 to 0.08552)
0.04308
(0.01803 to 0.06955)
0.03826
(0.03315 to 0.07737)
0.03784
(0.01826 to 0.05926)
14.Secondary Outcome
Title Terminal Elimination Half-life (t1/2,Term) of TMC435
Hide Description The table below shows the terminal plasma half-life for TMC435 in participants analyzed by genotype of hepatitis C virus infection. The terminal plasma half-life of a drug is the time in hours required for the concentration of a drug in the body to fall to 50% after having reached a state of equilibrium following administration.
Time Frame Predose, and at 0.5, 1, 2, 4, 6, 8, and 10 hours post-dose on Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat (ITT) population - all randomized participants who received at least 1 dose of study medication (TMC435).
Arm/Group Title Genotype 2 Genotype 3 Genotype 4 Genotype 5 Genotype 6
Hide Arm/Group Description:
Participants with chronic genotype 2 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 3 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Participants with chronic genotype 4 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 5 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
participants with chronic genotype 6 HCV infection who received 200 mg TMC435 as a single oral ((by mouth) dose once daily for 7 days.
Overall Number of Participants Analyzed 6 8 8 7 8
Median (Full Range)
Unit of Measure: hours
13.75
(7.998 to 39.04)
11.51
(8.105 to 17.09)
16.09
(9.966 to 38.44)
18.12
(8.959 to 20.91)
18.32
(11.70 to 37.95)
Time Frame From the date of signing of the Informed Consent Form onwards until 30-35 days after last TMC435 intake.
Adverse Event Reporting Description 5% cutoff is restricted to Total group. Adverse events reported for the total group rather than by genotype because enrollment numbers by genotype were small.
 
Arm/Group Title Total
Hide Arm/Group Description Participants with chronic genotype 2,3,4,5 or 6 HCV infection who received 200 mg TMC435 as a single oral (by mouth) dose once daily for 7 days
All-Cause Mortality
Total
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Total
Affected / at Risk (%)
Total   1/37 (2.70%) 
Gastrointestinal disorders   
Ileitis * 1  1/37 (2.70%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.1
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Total
Affected / at Risk (%)
Total   22/37 (59.46%) 
Cardiac disorders   
Palpitations * 1  2/37 (5.41%) 
Gastrointestinal disorders   
Diarrhoea * 1  4/37 (10.81%) 
Constipation * 1  2/37 (5.41%) 
Lip swelling * 1  2/37 (5.41%) 
General disorders   
Influenza like illness * 1  9/37 (24.32%) 
Fatigue * 1  4/37 (10.81%) 
Pyrexia * 1  2/37 (5.41%) 
Metabolism and nutrition disorders   
Anorexia * 1  3/37 (8.11%) 
Musculoskeletal and connective tissue disorders   
Back pain * 1  3/37 (8.11%) 
Myalgia * 1  3/37 (8.11%) 
Nervous system disorders   
Headache * 1  5/37 (13.51%) 
Skin and subcutaneous tissue disorders   
Pruritus * 1  4/37 (10.81%) 
*
Indicates events were collected by non-systematic assessment
1
Term from vocabulary, MedDRA Version 11.1
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Global Clinical DVLP Manager
Organization: Janssen Research & Development United States
Responsible Party: Tibotec Pharmaceuticals, Ireland
ClinicalTrials.gov Identifier: NCT00812331     History of Changes
Other Study ID Numbers: CR012604
TMC435350-TiDP16-C202 ( Other Identifier: Tibotec Pharmaceuticals, Ireland )
First Submitted: December 18, 2008
First Posted: December 22, 2008
Results First Submitted: December 24, 2013
Results First Posted: July 28, 2014
Last Update Posted: July 28, 2014