The purpose of this study is to assess anti-viral activity (inhibition of viral growth) of TMC435350 in genotype 2,3,4,5 and 6 hepatitis C virus infected participants who have never received treatment for their hepatitis C infection.
This is an open-label (all people know the identity of the intervention) study to assess the antiviral activity, safety, tolerability and pharmacokinetics (explores what the body does to the medication) of TMC435350 hereafter referred to as TMC435. Approximately 40 participants will be divided in 5 groups as per the genotype (8 participants each group). The study will include a screening phase (up to 6 weeks), treatment phase (7 days) and a follow-up phase (30-35 days after the last dose of study medication). Safety evaluations will include assessment of adverse events, clinical laboratory tests and cardiovascular safety.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
37
From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.
Unnamed facility
Bruges, Belgium
Unnamed facility
Brussels, Belgium
Unnamed facility
Ghent, Belgium
Unnamed facility
Leuven, Belgium
Change From Baseline in log10 Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels
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
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
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
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
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
Number of Participants Who Experienced Viral Breakthrough During TMC435 Treatment Period
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
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Unnamed facility
Berlin, Germany
Unnamed facility
Frankfurt, Germany
Unnamed facility
Freiburg im Breisgau, Germany
Unnamed facility
Hanover, Germany
Unnamed facility
Bangkok, Thailand
Unnamed facility
Chiang Mai, Thailand
Predose Plasma Concentration (C0h) of TMC435
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
Minimum Plasma Concentration (Cmin) of TMC435
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
Maximum Plasma Concentration (Cmax) of TMC435
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
Time to Reach the Maximum Plasma Concentration (Tmax) of TMC435
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
Average Steady-State Plasma Concentration (Css,av) of TMC435
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
Fluctuation Index (FI) of TMC435
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
Area Under the Plasma Concentration-time Curve From the Time of Administration up to 24 Hours After Dosing (AUC24h) of TMC435
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
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
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
Elimination Rate Constant of TMC435
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
Terminal Elimination Half-life (t1/2,Term) of TMC435
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