A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: ritonavir

Drug: tenofovir disoproxil fumarate

Drug: atazanavir

Drug: danoprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01592305

NP28104

Details and patient eligibility

About

This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.

Enrollment

40 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, inclusive
Body weight >/= 55 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 disease or condition
Positive for drugs of abuse at screening or prior to admission to the clinical site
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 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 allergy reaction
History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average