A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers
Phase 1
Completed
- Conditions
- Healthy Volunteer
- Interventions
- Registration Number
- NCT01591850
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This randomized, single-center, open-label, one-sequence, two-period crossover study in three parts will assess the effects of multiple doses of ketoconazole, rifampicin and ritonavir-boosted atazanavir on the pharmacokinetics of a single dose of RO5093151 in healthy male and female volunteers. In Period 1, subjects will receive a single oral dose of RO5093151. In Period 2, subjects will receive a single oral dose of RO5093151 and multiple oral doses of either ketoconazole, rifampicin or ritonavir-boosted atazanavir. Anticipated time on study is up to 8.5 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
Inclusion Criteria
- Healthy male and female subjects, 18 to 65 years of age. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history and complete physical examination
- Body mass index (BMI) 18 to 30 kg/m2
- Females of child-bearing potential must agree to use two effective methods of contraception, including a barrier method and an intrauterine non-hormonal device (set in place at least 3 months before first dosing) for the duration of the study and at least 1 month after last dosing
- Non-smoker for at least 90 days prior to screening
Exclusion Criteria
- Pregnant or lactating females
- History of drug abuse in the past 2 years, or suspicion of regular consumption of drugs of abuse, or positive result on drugs of abuse test
- History of alcoholism in the past 2 years, or positive alcohol test
- Positive for hepatitis B, hepatitis C or HIV infection
- Systemic , topical, intranasal or inhaled corticosteroid therapy for more than 2 weeks within 3 months prior to screening
- Participation in an investigational drug or device study within 90 days prior to screening
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 Ketoconazole DDI RO5093151 - 1 Ketoconazole DDI ketoconazole - 2 Rifampicin DDI RO5093151 - 2 Rifampicin DDI rifampicin - 3 ATZ/r DDI RO5093151 - 3 ATZ/r DDI atazanavir - 3 ATZ/r DDI ritonavir -
- Primary Outcome Measures
Name Time Method Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC) Pre-dose and up to 72 hours post-dose Part 2: Effect of multiple doses of rifampicin on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC) Pre-dose and up to 72 hours post-dose Part 3: Effect of multiple doses of ritonavir-boosted atazanavir on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC) Pre-dose and up to 72 hours post-dose
- Secondary Outcome Measures
Name Time Method Safety: Incidence of adverse events approximately 6 month RO5093151 metabolites: Plasma/urine concentrations Pre-dose and up to 72 hours post-dose Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only) Pre-dose and up to 24 hours post-dose