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NCT Number: NCT01181024

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

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.

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Key information

Conditions

Hepatitis C, Chronic, Healthy Volunteer Blood-Borne Infections Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Communicable Diseases Digestive System Diseases Flaviviridae Infections Graft vs Host Disease Hepatitis Hepatitis C Hepatitis, Viral, Human Immune System Diseases Infections Liver Diseases Lung Diseases Lung Diseases, Obstructive Organizing Pneumonia RNA Virus Infections Respiratory Tract Diseases Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Grafton, 1010, New Zealand

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo

Drug

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

RO5303253

Drug

Cohorts receiving single ascending doses

Primary outcomes

  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

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

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Aug 13, 2010
Registry last updated
Nov 2, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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