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

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.