Conditions: Hepatitis C
Keywords: Hepatitis C TMC435
Allocation: NON_RANDOMIZED | Intervention model: PARALLEL
Enrollment: 37
Healthy volunteers: no

Brief summary:
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.

Detailed description:
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.

Arms:
arm 1: Participants with chronic genotype 2 hepatitis C virus (HCV) infection arm 2: Participants with chronic genotype 3 HCV infection arm 3: Participants with chronic genotype 4 HCV infection arm 4: Participants with chronic genotype 5 HCV infection arm 5: Participants with chronic genotype 6 HCV infection

Interventions: intervention 1: TMC435
Intervention descriptions: intervention 1: From Day 1 to Day 7 all participants will take 200 mg TMC435350 as a single medication orally (by mouth) once daily.

Protocol document: