drugset / Trial / NCT01519336

A Study of Drug-Drug Interaction Between Darunavir and Danoprevir Administered Together With Low-Dose Ritonavir in Healthy Volunteers

NCT01519336

Phase 1 Completed 40 enrolled Hoffmann-La Roche
Non-randomizedCrossoverOpen-label

Summary

This randomized, open-label, multiple-dose, 2-period crossover study will evaluate potential drug-drug interactions between darunavir and danoprevir when administered together with low-dose ritonavir in healthy volunteers. In Period 1, subjects will be randomized to receive either darunavir or danoprevir together with low-dose ritonavir for 10 days. In Period 2, all subjects will receive darunavir plus danoprevir together with ritonavir for 10 days. Anticipated time on study treatment is 20 days.

Timeline

Start
2012-02
Primary completion
2012-03
Completion
2012-03

Drugs

EvaluationDrugModalityDoseRoute
Subject Darunavir Small molecule 600 mg
Subject Ritonavir Other / unclassified 100 mg
Subject danoprevir Small molecule 100 mg

Indications

No indication recorded.