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

• Status: Completed
• Trial end date: 2011-12-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche

Criteria

Inclusion Criteria:

• Healthy subjects (Part A) or patients with chronic hepatitis C infection (Part B), 18 to 60 years of age, inclusive

• Body mass index (BMI) between 18 and 32 kg/m2, inclusive, and a minimum weight of 45 kg

• Female subjects/patients must be surgically sterile or post-menopausal

• Male subjects/patients and their partners of childbearing potential must use 2 methods of contraception

• For HCV patients:

• Hepatitis C genotype 1 of > 6 months duration at screening

• HCV RNA quantifiable (Roche COBAS TaqMan HCV Test) at screening

• HCV treatment-naïve (no prior antiviral therapy for chronic hepatitis C with interferon-based therapy)

• Liver biopsy or non-invasive procedure within the past 2 years showing absence of cirrhosis

Exclusion Criteria:

• Pregnant or lactating women, and male partners of women who are pregnant or lactating

• Positive test for drugs of abuse

• History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams or 1 unit of alcohol

• History or symptoms of any significant disease or disorder

• History of active malignancy within the last 5 years, except for localized or in situ carcinoma (e.g. basal or squamous cell carcinoma of the skin)

• Positive for hepatitis B or HIV infection, and/ or for HCV for healthy volunteers (Part A)

• For HCV patients:

• Decompensated liver disease or impaired liver function as defined by any history of ascites, hepatic encephalopathy, hepatocellular carcinoma or bleeding esophageal varices, or prothrombin international normalized ratio (PTINR) >/= 2.0 at screening

• Evidence of cirrhosis and/or incomplete transition to cirrhosis

• Presence or history of non-hepatitis C liver disease