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

• Status: Completed
• Trial end date: 2015-09-28
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences

Criteria

Key Inclusion Criteria:

• All individuals:

• Screening laboratory values within defined thresholds for group

• Use of two effective contraception methods if female of childbearing potential or sexually active male

• For individuals with severe renal impairment:

• Stable chronic kidney disease

• Creatinine clearance (CLcr) < 30 mL/min

Key Exclusion Criteria:

• All individuals:

• Pregnant or nursing female or male with pregnant female partner

• Hepatitis B virus, hepatitis C virus (HCV) or HIV infection

• History of clinically significant illness or any other medical disorder that may interfere with the individual's treatment, assessment or compliance with the protocol

• For individuals with severe renal impairment:

• Anticipated to require dialysis within 90 days of study dosing

Note: Other protocol defined Inclusion/Exclusion criteria may apply.