A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers
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This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.
Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC) [ Time Frame: 16 time points up to 96 hours ]
Secondary Outcome Measures
Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine [ Time Frame: 16 time points up to 96 hours ]
Safety: Incidence of adverse events [ Time Frame: approximately 50 days ]
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Ages Eligible for Study:
18 Years to 45 Years (Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Male and female healthy volunteers, 18 to 45 years of age inclusive
Body mass index (BMI) 18.0 to 32.0 kg/m2
Weight >/= 50 kg
Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)
Pregnant or lactating females
Positive results for drugs of abuse in the urine 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 the first dose of study medication
Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
Routine chronic use of more than 2 g acetaminophen daily
Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
History of clinically significant disease or disorder
History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)