Healthy Volunteer
Conditions
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.
Interventions
DRUGRO5093151
Single oral dose
DRUGatazanavir
Multiple oral doses
DRUGketoconazole
Multiple oral doses
DRUGrifampicin
Multiple oral doses
DRUGritonavir
Multiple oral doses
Sponsors
Hoffmann-La Roche
Study design
Intervention model
PARALLEL
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 |
Countries
United States
Outcome results
None listed