drugset / Trial / NCT01591850

A Drug-Drug Interaction Study of Ketoconazole, Rifampicin and Ritonavir-Boosted Atazanavir With Single-Dose RO5093151 in Healthy Volunteers

NCT01591850

Phase 1 Completed 51 enrolled Hoffmann-La Roche
Parallel-groupOpen-label

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.

Timeline

Start
2011-09
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified Oral
Subject Ketoconazole Small molecule Oral
Subject RO5093151 Unknown Oral
Subject Rifampin Small molecule Oral
Subject Ritonavir Other / unclassified Oral

Indications

No indication recorded.