Status:
COMPLETED
A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Healthy Volunteer
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonav...
Eligibility Criteria
Inclusion
- Adult healthy volunteers, 18 - 60 years of age
- Female subjects must be surgically sterile or post-menopausal
- Male subjects and their partners of child-bearing potential must use to methods of contraception for the duration of the study and for three months after the last drug administration
- Agree to abstain from strenuous exercise for three days before dosing and throughout the study (including washout period and follow-up visit)
Exclusion
- History or evidence of any clinically significant disease or disorder
- Pregnant or lactating women
- Male partners of women who are lactating or trying to become pregnant
- Current smokers or subjects who have discontinued smoking less than six months prior to first dosing
- Positive alcohol breath test; suspicion of regular consumption of drugs of abuse
- Positive for hepatitis B, hepatitis C or HIV infection
- Participation in an investigational drug, biologic, or device study within three months before first study drug administration
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2011
Estimated Enrollment :
52 Patients enrolled
Trial Details
Trial ID
NCT01398293
Start Date
August 1 2011
End Date
November 1 2011
Last Update
November 2 2016
Active Locations (1)
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1
Strasbourg, France, 67064