drugset / Trial / NCT00623649
Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection
Phase 1
Completed
42 enrolled
Vertex Pharmaceuticals Incorporated
Duke Clinical Research Institute · collabViroChem Pharma · collab
RandomizedSingle-groupQuadruple-blindTreatment
Summary
The purpose of this study is to determine whether a 3-day course of therapy with orally administered VCH-916 given at different dosages can effectively reduce the amount of circulating virus (i.e., viral load) in patients with early-stage chronic hepatitis C-infection. This study will also evaluate the safety and tolerability of treatment with VCH-916. Blood samples will also be taken to measure the levels of VCH-916 present in plasma at various time points during the treatment period.
Timeline
- Start
- 2007-11
- Primary completion
- 2008-10
- Completion
- 2008-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | VCH 916 | Unknown | 100 mg | Oral |
| Subject | VCH 916 | Unknown | 200 mg | Oral |
| Subject | VCH 916 | Unknown | 300 mg | Oral |
| Subject | VCH 916 | Unknown | 400 mg | Oral |