A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: danoprevir

Drug: efavirenz

Drug: ritonavir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01588002

NP28103

Details and patient eligibility

About

This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.

Enrollment

40 patients

Sex

All

Ages

18 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Healthy male and female non-smoking subjects, 18 to 55 years of age
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
Weight >/= 50.0 kg
Body mass index (BMI) 18.0 - 32.0 kg/m2

Exclusion criteria

Pregnant or lactating women or males with female partners who are pregnant or lactating
History of any clinically significant medical condition which may impact the safety of the participant
Positive results 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 pill, patches, or injectable, implantable devices) within 30 days before the first dose of study medication
Use of 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 reaction
History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average; alcohol consumption will be prohibited 72 hours prior to entry in the clinical site center and throughout the entire study