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

This study has been completed.
Sponsor:
Information provided by:
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01181024
First received: August 12, 2010
Last updated: November 21, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention Phase
Hepatitis C, Chronic, Healthy Volunteer
 Drug: RO5303253
Drug: Placebo
 Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Safety and tolerability: Adverse events, laboratory parameters, ECG, blood pressure [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]
  • Pharmacokinetics: Plasma and urine concentrations of RO5303253 and its main metabolite RO1080713 [ Time Frame: approximately 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Effect of food intake on pharmacokinetics in healthy volunteers [ Time Frame: Days 1-4 ] [ Designated as safety issue: No ]
  • Pharmacodynamics (viral responses) and drug resistance profiling in chronic hepatitis C patients [ Time Frame: From baseline to Day 15 ] [ Designated as safety issue: No ]

Enrollment: 82
Study Start Date: April 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: A: HV ascending dose Drug: RO5303253
Cohorts receiving single ascending doses
Drug: Placebo
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)
Experimental: B: HV food effect Drug: RO5303253
Single dose
Drug: Placebo
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)
Experimental: C: Hepatitis C Drug: RO5303253
Multiple doses
Drug: Placebo
matching RO5303253 placebo, administered as single dose (Parts A + B) or multiple dose (Part C)

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01181024

Locations
New Zealand
Auckland, New Zealand, 1150
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Disclosures Group, Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01181024     History of Changes
Other Study ID Numbers: PP25195, 2009-018183-96
Study First Received: August 12, 2010
Last Updated: November 21, 2011
Health Authority: New Zealand: Ministry of Health

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis, Chronic
Hepatitis C
Hepatitis C, Chronic
Liver Diseases
Digestive System Diseases
 Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections

ClinicalTrials.gov processed this record on May 22, 2013