A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers



Status:Completed
Conditions:Healthy Studies
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 55
Updated:8/3/2016
Start Date:February 2012
End Date:March 2012

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A Study to Evaluate the Potential Drug-Drug Interaction Between Darunavir and Danoprevir When Administered Together With Low-Dose Ritonavir in Healthy Volunteers

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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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
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