Roche trials database

Trial information

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

Status:

Completed

Protocol number:

PP25195

Sponsor:

Hoffmann-La Roche

Company division:

Pharmaceutical

Official Scientific 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

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. Target sample size is 82.

Study phase:

I

Study type:

Interventional; Other; Randomized; Double Blind; Parallel; Pharmacokinetics/dynamics study

Conditions:

• Healthy Volunteer
• Hepatitis C, Chronic

Primary outcome:

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

Key secondary outcomes:

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

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:

Males or Females

Age limits:

Min: 18 years Max: 60 years

Accepts healthy volunteers:

No

Anticipated start date:

April, 2010

Trial registration date:

02.08.2010

Date last updated:

04.06.2013

This trial was conducted at the following locations:

New Zealand

• AUCKLAND

Link to trial result