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.
Study Type
INTERVENTIONAL
Masking
NONE
Enrollment
51
Single oral dose
Multiple oral doses
Multiple oral doses
Multiple oral doses
Multiple oral doses
Unnamed facility
Merritt Island, Florida, United States
Part 1: Effect of multiple doses of ketoconazole on single-dose pharmacokinetics of RO5093151 and metabolites: Area under the concentration-time curve (AUC)
Time frame: 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)
Time frame: 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)
Time frame: Pre-dose and up to 72 hours post-dose
Safety: Incidence of adverse events
Time frame: approximately 6 month
RO5093151 metabolites: Plasma/urine concentrations
Time frame: Pre-dose and up to 72 hours post-dose
Pharmacodynamics: Area under the effect curve (AUEC) for plasma cortisol/cortisone (Part 1 only)
Time frame: Pre-dose and up to 24 hours post-dose
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