Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGcyclosporine
Single oral dose
DRUGdanoprevir
Single oral dose
DRUGritonavir
Single oral dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Effect of single dose of cyclosporine on pharmacokinetics of ritonavir-boosted danoprevir: maximum plasma concentration (Cmax)/area under the concentration-time curve (AUC) | 16 time points up to 96 hours |
Secondary
| Measure | Time frame |
|---|---|
| Effect of single dose of ritonavir-boosted danoprevir on pharmacokinetics of cyclosporine | 16 time points up to 96 hours |
| Safety: Incidence of adverse events | approximately 50 days |
Countries
United States
Outcome results
None listed