A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
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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).
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
Study Start Date
Primary Completion Date
Study Completion Date
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Ages Eligible for Study:
18 Years to 60 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
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
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