A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01592305
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description S1/S2 P2 DNV/r + ATZ atazanavir - S2 P1 ATZ/r atazanavir - S2 P1 ATZ/r ritonavir - S1 P1 TDF + DNV/r danoprevir - S1 P1 TDF + DNV/r ritonavir - S1 P1 TDF + DNV/r tenofovir disoproxil fumarate - S1/S2 P2 DNV/r + ATZ danoprevir - S1/S2 P2 DNV/r + ATZ ritonavir -
- Primary Outcome Measures
Name Time Method Pharmacokinetics of tenofovir disoproxil fumarate and atazanavir when coadministered with danoprevir/ritonavir: Area under the concentration-time curve (AUC) Pre-dose, and up to 48 hours post-dose Days 1, 8, 11, 16, 20 Pharmacokinetics of danoprevir and ritonavir when coadministered with tenofovir disoproxil fumarate and atazanavir: Area under the concentration-time curve (AUC) Pre-dose, and up to 24 hours post-dose Days 10, 11, 16, 20
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 2 months