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.
Timeline
- Start
- 2011-06
- Primary completion
- 2011-11
- Completion
- 2011-11
Outcome
Missed primary endpoint
Stopped: “Antiviral activity was considered insufficient to warrant further clinical development of TMC649128.”
release “Completion of phase Ib trial on polymerase inhibitor TMC649128 against hepatitis C. However, the antiviral efficacy goal was not achieved, and clinical development was discontinued.” medivir.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TMC649128 | Small molecule | 1000 mg | Oral |
| Subject | TMC649128 | Small molecule | 2000 mg | Oral |
| Subject | TMC649128 | Small molecule | 3000 mg | Oral |