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 (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01181024
First received: August 12, 2010
Last updated: July 7, 2014
Last verified: July 2014
  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 vol unteers will be randomized to receive single ascending doses of RO5303253 or pla cebo. In Part 2, healthy volunteers will receive a single dose of RO5303253 or p lacebo in a cross-over design (with a washout period of at least 7 days) to asse ss 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:


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: October 2010
Primary Completion Date: October 2010 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
New Zealand
Grafton, New Zealand, 1010
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: 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: July 7, 2014
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 July 28, 2014