Hepatitis C, Chronic, Healthy Volunteer Clinical Trial
Official title:
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
| Verified date | November 2016 |
| Source | Hoffmann-La Roche |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | New Zealand: Ministry of Health |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 82 |
| Est. completion date | October 2010 |
| Est. primary completion date | October 2010 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Both |
| Age group | 18 Years to 60 Years |
| Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Hoffmann-La Roche |
New Zealand,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure | approximately 6 months | No | |
| Primary | Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713 | approximately 6 months | No | |
| Secondary | Effect of food intake on pharmacokinetics in healthy volunteers | Days 1-4 | No | |
| Secondary | Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients | From baseline to Day 15 | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01371162 -
A Study of RO5428029 in Healthy Volunteers and Patients With Chronic Hepatitis C
|
Phase 1 |