drugset / Trial / NCT01398293

A Study of Danoprevir in Combination With Low-Dose Ritonavir in Healthy Subjects

NCT01398293

Phase 1 Completed 52 enrolled Hoffmann-La Roche
RandomizedCrossoverDouble-blind

Summary

This single-dose, randomized, double-blind, double-dummy, placebo-controlled, positive-controlled four-way crossover study will evaluate the effect of a single dose of danoprevir with low-dose ritonavir on the QC/QTc interval in healthy volunteers. Subjects will be randomly assigned to one of four sequences with treatments of A: therapeutic dose of danoprevir plus ritonavir (DNV/r), B: supratherapeutic dose of DNV/r, C: moxifloxacin and D: placebo, with a washout period of at least 7 days between treatments.

Timeline

Start
2011-08
Primary completion
2011-11
Completion
2011-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxifloxacin Small molecule 400 mg Oral
Subject Ritonavir Other / unclassified 100 mg Oral
Subject danoprevir Small molecule 100 mg Oral
Subject danoprevir Small molecule 400 mg Oral

Indications

No indication recorded.