A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 45
Updated:8/3/2016
Start Date:December 2011
End Date:February 2012

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A Drug-Drug Interaction Study Between Danoprevir/Low-dose Ritonavir and Cyclosporine, a Potent Inhibitor of OATP, in Healthy Subjects

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.


Inclusion Criteria:

- 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

- Nonsmoker

- 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)

Exclusion Criteria:

- 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)
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