drugset / Trial / NCT01592305

A Study of Drug-Drug Interaction Between Danoprevir Coadministered With Low-Dose Ritonavir and Tenofovir Disoproxil Fumarate or Atazanavir

NCT01592305

Phase 1 Completed 40 enrolled Hoffmann-La Roche
Parallel-groupOpen-label

Summary

This randomized, open-label, multiple-treatment multiple-dose, 2-period, 2-sequence study will evaluate potential drug-drug interactions between danoprevir (DNV) when coadministered with low-dose ritonavir (r) and tenofovir disoproxil fumarate (TDF) or atazanavir (ATZ) in healthy volunteers. Subjects will be randomized to receive in Period 1 either single oral doses of TDF and multiple oral doses of DNV/r or multiple oral doses of ATZ/r. In Period 2, all subjects will receive multiple oral doses of DNV/r plus ATZ. Anticipated time on study treatment is up to 20 days.

Timeline

Start
2012-05
Primary completion
2012-06
Completion
2012-06

Drugs

EvaluationDrugModalityDoseRoute
Subject Atazanavir Other / unclassified Oral
Subject Ritonavir Other / unclassified Oral
Subject Tenofovir disoproxil fumarate Small molecule Oral
Subject danoprevir Small molecule Oral

Indications

No indication recorded.