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

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: ritonavir

Drug: danoprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01592318

NP28136

Details and patient eligibility

About

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.

Enrollment

42 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

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