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

• Status: Completed
• Trial end date: 2012-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Darunavir; Lactams; Ritonavir

Criteria

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