A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers
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This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.
Effect of coadministration of darunavir (DRV), danoprevir (DNV) and ritonavir (RTV) on DRV/DNV/RTV pharmacokinetics: Area under the concentration-time curve (AUC) [ Time Frame: approximately 2 months ]
Secondary Outcome Measures
Safety: Incidence of adverse events [ Time Frame: approximately 2 months ]
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Ages Eligible for Study:
18 Years to 55 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Healthy non-smoking male and female adults, 18 - 55 years of age, inclusive
Healthy status defined by absence of evidence of any active or chronic disease
Medical history without major, recent, or ongoing pathology
Weight >/= 55 kg
Body mass index (BMI) 18.0 - 32.0 kg/m2
Ability and willingness to abstain from alcohol, xanthine-containing beverages or food (coffee, tea, cola, chocolate, "energy drinks") from 72 hours prior to entry in the clinical site center until discharge
Females of child-bearing potential and males and their female partners of child-bearing potential must agree to use 2 forms of contraception, one of which must be a barrier method, during the study and for 90 days after the last drug administration. Acceptable barrier forms of contraception are condom and diaphragm; acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device (IUD) and/or spermicide
Pregnant or lactating females or males with female partners who are pregnant or lactating
Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections
Positive test for drugs of abuse at screening or prior to admission to the clinical site during any study period
Positive for hepatitis B, hepatitis C or HIV infection
Current smokers or subjects who have discontinued smoking less than 6 months prior to first dose of study medication
Use of hormonal contraceptives within 30 days before the first dose of study medication
History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity