drugset / Trial / NCT02402452

Pharmacokinetics of Voxilaprevir in Adults With Normal Renal Function and Severe Renal Impairment

NCT02402452

Phase 1 Completed 20 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the pharmacokinetics, safety, and tolerability of voxilaprevir (formerly GS-9857) in participants with severe renal impairment and matched healthy control participants.

Timeline

Start
2015-05-05
Primary completion
2015-09-28
Completion
2015-09-28

Publications

  • Results Lawitz E, Marbury T, Kirby BJ, Au NT, Mathias A, Stamm LM, Wei H, Sajwani K, Klein G, Gane E, Robson R. The effect of renal or hepatic impairment on the pharmacokinetics of GS-9857, a pangenotypic HCV NS3/4A protease inhibitor. The International Liver Congress; 2016; Barcelona, Spain.

Drugs

EvaluationDrugModalityDoseRoute
Subject Voxilaprevir Small molecule 100 mg Oral