Healthy Volunteer
Conditions
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.
Interventions
DRUGdanoprevir
100 mg single dose orally
single oral dose
DRUGmoxifloxacin
400 mg single dose orally
DRUGmoxifloxacin placebo
single oral dose
DRUGritonavir
100 mg single dose orally
single oral dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose | approximately 9 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Pharmacokinetics: Plasma concentrations | approximately 9 weeks |
| Safety: Incidence of adverse events | approximately 9 weeks |
| Cardiac response: Electrocardiogram (ECG) | approximately 9 weeks |
| Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes | approximately 9 weeks |
Countries
France
Outcome results
None listed