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

Hoffmann-La Roche0 sites42 target enrollmentJune 2011

ConditionsHepatitis C, Chronic, Healthy Volunteer

InterventionsRO5428029 placebo

DrugsRO5428029 placebo

Overview

Phase: Phase 1
Intervention: RO5428029
Conditions: Hepatitis C, Chronic, Healthy Volunteer
Sponsor: Hoffmann-La Roche
Enrollment: 42
Primary Endpoint: Parts A + B: Safety: Incidence of adverse events
Status: Completed
Last Updated: 9 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief 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).

Registry

clinicaltrials.gov

Start Date

June 2011

End Date

December 2011

Last Updated

9 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Hoffmann-La Roche

Responsible Party

Sponsor

Eligibility 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