Healthy Volunteer
Conditions
Brief summary
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.
Interventions
DRUGdanoprevir
Fixed dose combination tablet with ritonavir, single oral dose
DRUGritonavir
Fixed dose combination tablet with danoprevir, single oral dose
Sponsors
Hoffmann-La Roche
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Relative bioavailability of danoprevir: Area under the concentration-time curve (AUC) | Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 |
| Pharmacokinetics of ritonavir: Area under the concentration-time curve (AUC) | Pre-dose and up to 24 hours post-dose Days 1, 8 and 15 |
Secondary
| Measure | Time frame |
|---|---|
| Safety: Incidence of adverse events | approximately 2 months |
Countries
New Zealand
Outcome results
None listed