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

Roche

Status and phase: Completed; Phase 1

Conditions: Hepatitis C, Chronic, Healthy Volunteer

Treatments: Drug: RO5428029; Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01371162

NP25733

Details and patient eligibility

About

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).

Enrollment: 42 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

42 participants in 4 patient groups, including a placebo group

A1 Healthy Volunteers

Experimental group

Treatment:

Drug: RO5428029

A2

Placebo Comparator group

Treatment:

Drug: placebo

B1 HCV Infection

Experimental group

Treatment:

Drug: RO5428029

B2

Placebo Comparator group

Treatment:

Drug: placebo