A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01398293
- Lead Sponsor
- Hoffmann-La Roche
- 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 ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 52
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description A moxifloxacin placebo - C danoprevir placebo - C moxifloxacin - C ritonavir placebo - D danoprevir placebo - D moxifloxacin placebo - A danoprevir - A ritonavir - B danoprevir - B moxifloxacin placebo - B ritonavir - D ritonavir placebo -
- Primary Outcome Measures
Name Time Method Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose approximately 9 weeks
- Secondary Outcome Measures
Name Time Method Pharmacokinetics: Plasma concentrations approximately 9 weeks Cardiac response: Electrocardiogram (ECG) approximately 9 weeks Safety: Incidence of adverse events approximately 9 weeks Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes approximately 9 weeks