drugset / Trial / NCT01714154

A Safety And Pharmacokinetic Study of Setrobuvir Alone and In Combination With Ritonavir-Boosted Danoprevir in Subjects With Mild Hepatic Impairment Compared to Healthy Controls

NCT01714154

Phase 1 Completed 18 enrolled Hoffmann-La Roche
Non-randomizedParallel-groupOpen-label

Summary

This multi-center, fixed-sequence, open-label, multiple-dose, 2-period study will evaluate the safety, tolerability and pharmacokinetics of setrobuvir alone or in combination with ritonavir-boosted danoprevir in subjects with mild hepatic impairment compared to healthy controls. All subjects will receive multiple doses of setrobuvir orally for 10 days in Period 1 and multiple doses of setrobuvir plus ritonavir-boosted danoprevir orally for 10 days in Period 2, with a washout phase of at least 9 days between treatments.

Timeline

Start
2012-11
Primary completion
2013-05
Completion
2013-05

Drugs

EvaluationDrugModalityDoseRoute
Subject Ritonavir Other / unclassified 100 mg Oral
Subject danoprevir Small molecule 100 mg Oral
Subject setrobuvir Small molecule 200 mg Oral

Indications

No indication recorded.