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

Phase 1

Completed

• Conditions: Hepatitis C, Chronic, Healthy Volunteer
• Interventions: Drug: Placebo; Drug: RO5303253

• Registration Number: NCT01181024
• Lead Sponsor: Hoffmann-La Roche

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-08-12
• Study First Submitted QC: 2010-08-12
• Study First Posted: 2010-08-13
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-01
• Last Update Posted: 2016-11-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 82

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A: HV ascending dose	Placebo	-
A: HV ascending dose	RO5303253	-
B: HV food effect	Placebo	-
B: HV food effect	RO5303253	-
C: Hepatitis C	Placebo	-
C: Hepatitis C	RO5303253	-

Primary Outcome Measures

Name	Time	Method
Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure	approximately 6 months
Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713	approximately 6 months

Secondary Outcome Measures

Name	Time	Method
Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients	From baseline to Day 15
Effect of food intake on pharmacokinetics in healthy volunteers	Days 1-4