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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01181024

Enrollment

Registered

2010-08-13

Start date

2010-04-30

Completion date

2010-10-31

Last updated

2016-11-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hepatitis C, Chronic, Healthy Volunteer

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.

Interventions

DRUGPlacebo

matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

DRUGRO5303253

Cohorts receiving single ascending doses

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
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

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

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026