TMC649128HPC1002 - a Trial inGenotype 1 Hepatitis C Virus (HCV) - Infected Participants to Determine the Safety, Tolerability, Pharmacokinetics and Antiviral Activity of TMC649128, Alone and Combined With Pegylated Interferon + Ribavirin

Summary

The purpose of this study is to determine in genotype 1 Hepatitis C Virus (HCV)-infected participants, the safety, tolerability, pharmacokinetics (how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) and antiviral activity of repeated doses of TMC649128 given as monotherapy and given in combination with pegylated interferon + ribavirin. We assess the pharmacokinetic/pharmacodynamic (how the study medication affects the body) (PK/PD) relationship for antiviral activity, active metabolite and safety of TMC649128 and its metabolites. We determine the short term safety and tolerability of the co-administration of TMC649128 and pegylated interferon + ribavirin during multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We explore the effect of pegylated interferon + ribavirin on the pharmacokinetics of TMC649128 during the multiple dosing for 14 days in treatment-naive genotype 1 HCV-infected participants. We also assess in a preliminary way the short term antiviral effect of the combination of TMC649128 with pegylated interferon + ribavirin during a 14-day dosing period in treatment-naive genotype 1 HCV-infected participants.

Conditions

• Hepatitis C Virus

Interventions

DRUG

placebo.

panel 1: 2 participants receive placebo at a q24h regimen.

DRUG

placebo.

panel 3: 2 participants receive placebo. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.

DRUG

TMC649128.

panel 2, arm 1: 8 participants receive a q12h regimen of TMC649128 at a selected dose based on results of panel 1.

DRUG

placebo.

panel 2, arm 2: 2 participants receive placebo at a q24h regimen.

DRUG

placebo

panel 4, arm 1: 10 participants receive PegIFN a-2a/RBV in combination with placebo, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3.

DRUG

TMC649128

panel 4, arm 2: 10 participants receive PegIFN a-2a/RBV in combination with TMC649128, administered q12h or q24h, for 14 days. Actual dose and dose regimen (12h or 24h) is to be selected based on panels 1, 2 and 3.

DRUG

TMC649128.

panel 2, arm 2: 8 participants receive a q24h regimen TMC649128 at a dose based on results of panel 1.

DRUG

TMC649128

panel 3: 8 participants receive TMC649128. Actual dose and dose regimen (q12h or q24h) to be selected based on the results of the panels 1 and 2.

DRUG

TMC649128.

panel 1: 8 participants receive a q24h regimen at 1000 mg of TMC649128.

DRUG

placebo.

panel 2, arm 1: 2 participants receive placebo at a q12h regimen.

Sponsors & Collaborators

• Tibotec BVBA

  lead INDUSTRY

Principal Investigators

• Tibotec-Virco Virology BVBA Clinical Trial · Tibotec BVBA

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-06-30

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• Netherlands
• Poland

Study Locations