drugset / Trial / NCT01588002

A Study of Potential Drug-Drug Interaction Between Efavirenz and Danoprevir With Low Dose Ritonavir in Healthy Volunteers

NCT01588002

Phase 1 Completed 40 enrolled Hoffmann-La Roche
RandomizedCrossoverOpen-label

Summary

This phase 1, randomized, open-label, multiple-dose, 2-sequence, 2-period crossover study will evaluate potential drug-drug interaction between efavirenz and danoprevir with low-dose ritonavir in healthy volunteers. In Period 1. subjects will be randomized to receive multiple oral doses of either danoprevir with ritonavir or efavirenz for 14 days. In Period 2, all subjects will receive multiple oral doses of the combination danoprevir with ritonavir and efavirenz for 14 days. Anticipated time on study treatment is 28 days.

Timeline

Start
2012-04
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Efavirenz Other / unclassified Oral
Subject Ritonavir Other / unclassified Oral
Subject danoprevir Small molecule Oral

Indications

No indication recorded.