This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Masking
NONE
Enrollment
40
Unnamed facility
Lenexa, Kansas, United States
Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Cmax
Time frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28
Pharmacokinetics of efavirenz, danoprevir and ritonavir in coadministration: Area under the concentration-time curve (AUC)
Time frame: Pre-dose and up to 24 hours post-dose on Days 14 and 28
Safety: Incidence of adverse events
Time frame: approximately 2 months
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