NCT00623649

Safety,Tolerability and Pharmacokinetics of Multiple Ascending Doses of VCH 916 in Subjects With Chronic Hep C Infection

A Phase 1B, Multicentre, Randomized, Double-Blinded, and PLacebo-Controlled Study of the Antiviral Activity, Safety, Tolerability, and PK of Multiple Ascending Doses of VCH-916 in the Treatment Naive or Experienced Subjects With Chronic Hep C-Infection.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (actual)
• Sponsor: Vertex Pharmaceuticals Incorporated · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HCV Infection

Interventions

Type	Name	Description
DRUG	VCH 916	Dose escalation study with a full review of all safety data following each cohort.
DRUG	Placebo	Dose escalation study with a full review of all safety data following each cohort.

Timeline

• Start date: 2007-11-01
• Primary completion: 2008-10-01
• Completion: 2008-10-01
• First posted: 2008-02-26
• Last updated: 2014-04-04

Locations

5 sites across 3 countries: United States, Canada, Puerto Rico