A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
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.
Full Title of Study: “A Single Ascending Dose Tolerability and Pharmacokinetic Study of RO5303253 With a Pilot Food-effect Investigation in Healthy Subjects and Exploratory Pharmacokinetic, Pharmacodynamic, and Safety Assessments in Chronic Hepatitis C Genotype 1 Patients Following 5 Days of Oral Administration”
Study Type
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Masking: Double (Participant, Investigator)
- Study Primary Completion Date: October 2010
Interventions
- Drug: Placebo
- matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)
- Drug: RO5303253
- Cohorts receiving single ascending doses
- Drug: RO5303253
- Single dose
- Drug: RO5303253
- Multiple doses
Arms, Groups and Cohorts
- Experimental: A: HV ascending dose
- Experimental: B: HV food effect
- Experimental: C: Hepatitis C
Clinical Trial Outcome Measures
Primary Measures
- 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 Measures
- 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
Participating in This Clinical Trial
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
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: 60 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
Investigator Details
- Lead Sponsor
- Hoffmann-La Roche
- Provider of Information About this Clinical Study
- Sponsor
- Overall Official(s)
- Clinical Trials, Study Director, Hoffmann-La Roche
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