Adaptive Phase I HCV Study With Nucleoside Analogue, in Combination With Interferon and Ribavirin

Summary

This is an adaptive Phase I study to evaluate RO5024048 in the following groups: * Healthy Volunteers (Part 1 - Single Ascending Dose Study) -Enrollment completed * Hepatitis C virus (HCV) genotype 1 infected patients who have failed interferon therapy (Part 2- Multiple Ascending Dose Study)-Enrollment Completed * HCV genotype 1-infected patients who are treatment naive, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)-Currently Enrolling * HCV genotype 2-3 infected patients who have previously been treated with interferon but who did not respond, to be dosed in combination with PEG-IFN and RBV (Part 3 - Combination Dose Study)- Currently enrolling The study aims to determine if RO5024048 is safe and well-tolerated in healthy people and in people infected with hepatitis C virus. The amount of RO5024048 in the blood will be measured during the study and the amount of hepatitis C virus in the blood after each dose will also be measured. During Part 3 of the study, RO5024048 will be given with PEG-IFN and RBV, two drugs currently used and approved for the treatment of HCV.

Timeline

Start

2006-10

Primary completion

2008-09

Completion

2008-09

Drugs

Indications