Status:
COMPLETED
A Study on Safety, Tolerability and Pharmacokinetics of RO5303253 in Healthy Volunteers and Patients With Chronic Hepatitis C Genotype 1
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Hepatitis C, Chronic, Healthy Volunteer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
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 genot...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
April 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 1 2010
Estimated Enrollment :
82 Patients enrolled
Trial Details
Trial ID
NCT01181024
Start Date
April 1 2010
End Date
October 1 2010
Last Update
November 2 2016
Active Locations (1)
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1
Grafton, New Zealand, 1010