A Study of The Relative Bioavailability of Ritonavir-Boosted Danoprevir Fixed Dose Combination Tablets in Healthy Volunteers

• Status: Completed
• Trial end date: 2012-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This randomized, open-label, crossover study will evaluate the relative bioavailability of ritonavir-boosted danoprevir fixed dose combination tablets (FDC) as compared to ad hoc combination of reference tablets of danoprevir and ritonavir in healthy volunteers. Subjects will be randomized to 1 of 6 treatment sequences to receive single oral doses of either an FDC of danoprevir and ritonavir or danoprevir and ritonavir as separate tablets. In a crossover design, subjects will participate in 3 study periods with at least a 7-day washout between periods. In Part 2, single dose administration of film-coated FDCs will be compared to reference tablets.

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

Details

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

Criteria

Inclusion Criteria:

• Male and female volunteers, 18 to 55 years of age

• Body weight >/= 50.0 kg

• Body mass index (BMI) 18.0 - 32.0 kg/m2

• Healthy non-smoking subjects. Healthy status will be defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and a complete physical examination

• Medical history without major, recent, or ongoing pathology

• Females of childbearing potential and males and their female partners 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

Exclusion Criteria:

• Pregnant or lactating women or males with female partners who are pregnant or lactating

• Any history of clinically significant cardiovascular or cerebrovascular disease, hypertension, and/or infections

• Positive result 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 (e.g. birth control pills, patches, injectable, implantable devices) within 30 days before the first dose of study medication

• Use of an investigational drug or device within 30 days of the first dose of study medication (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer

• History of drug-related allergic reactions or hepatotoxicity

• History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average