A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers

Roche

Status and phase

Completed

Phase 1

Conditions

Healthy Volunteer

Treatments

Drug: danoprevir

Drug: ritonavir

Drug: cyclosporine

Study type

Interventional

Funder types

Industry

Identifiers

NCT01514968

NP27947

Details and patient eligibility

About

This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.

Enrollment

18 patients

Sex

All

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Male and female healthy volunteers, 18 to 45 years of age inclusive
Body mass index (BMI) 18.0 to 32.0 kg/m2
Weight >/= 50 kg
Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
Nonsmoker
Females of childbearing potential and males and their female partner(s) 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 (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)

Exclusion criteria

Pregnant or lactating females
Positive results for drugs of abuse in the urine 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 the first dose of study medication
Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
Routine chronic use of more than 2 g acetaminophen daily
Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
History of clinically significant disease or disorder
History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)