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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
DOUBLE
Enrollment
52
Unnamed facility
Strasbourg, France
Threshold pharmacological effect on cardiac repolarization as detected by changes in the QT/QTc interval following single dose
Time frame: approximately 9 weeks
Pharmacokinetics: Plasma concentrations
Time frame: approximately 9 weeks
Safety: Incidence of adverse events
Time frame: approximately 9 weeks
Cardiac response: Electrocardiogram (ECG)
Time frame: approximately 9 weeks
Correlation between pharmacokinetics (plasma concentrations) and QT/QTc interval changes
Time frame: approximately 9 weeks
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400 mg single dose orally
single oral dose
100 mg single dose orally
single oral dose