A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C

Hepatitis C, Chronic, Healthy Volunteer Clinical Trial

Official title: A Multi-Center, Randomized, Double-Blind, Multiple Ascending Dose, Placebo-Controlled, Parallel Group 2-Part Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamic of the HCV Nucleoside Inhibitor RO5428029 in Healthy Subjects and in CHC Genotype 1 Infected Patients

Status Completed

Clinical Trial Summary

This 2-part, randomized, double-blind, placebo-controlled study will assess the safety, pharmacokinetics and pharmacodynamics of RO5428029 in healthy volunteers and patients with hepatitis C infection. Cohorts will be randomized to receive either RO5428029 in ascending doses or placebo for up to 7 days (patients) or up to 14 days (healthy volunteers).

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• Hepatitis C, Chronic
• Hepatitis C, Chronic, Healthy Volunteer

• NCT number: NCT01371162
• Study type: Interventional
• Source: Hoffmann-La Roche
• Status: Completed
• Phase: Phase 1
• Start date: June 2011
• Completion date: December 2011