A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1

Hoffmann-La Roche82 enrolled

Overview

This randomized, double-blind, placebo controlled, 3 part study will assess the safety, tolerability and pharmacokinetics of RO5303253 in healthy volunteers and patients with chronic hepatitis C genotype 1. In Part A, cohorts of healthy volunteers will be randomized to receive single ascending doses of RO5303253 or placebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or placebo in a cross-over design (with a washout period of at least 7 days) to assess food effects on pharmacokinetics. In Part 3, patients with chronic hepatitis C will be randomized ro receive either RO5303253 or placebo for 5 days.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Masking

DOUBLE

Enrollment

Conditions

Hepatitis C, Chronic, Healthy Volunteer

Interventions

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers or patients with chronic hepatitis C genotype 1, 18 to 60 years of age * Patients must be treatment-naïve for antiviral therapy for chronic hepatitis C with interferon based therapy * Body mass index (BMI) 18 - 32 kg/m2 inclusive, minimum weight 45 kg * Females must be surgically sterile or menopausal * Male subjects and their partners of childbearing potential must use 2 methods of contraception throughout the study and for 70 days after the last dose Exclusion Criteria: * Pregnant or lactating women and male partners of women who are pregnant or lactating * Women with reproductive potential * Positive for hepatitis B or HIV (or hepatitis C for healthy volunteers) at screening * For hepatitis C patients: decompensated liver disease or impaired liver function, evidence of cirrhosis documented at any time, presence or history of non-hepatitis C chronic liver disease

Outcomes

Primary Outcomes

Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure

Time frame: approximately 6 months

Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713

Time frame: approximately 6 months

Secondary Outcomes

Effect of food intake on pharmacokinetics in healthy volunteers

Time frame: Days 1-4

Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients

Time frame: From baseline to Day 15