Study to Evaluate the Pharmacokinetics of Velpatasvir in Participants With Normal Renal Function and Severe Renal Impairment

• Status: Completed
• Trial end date: 2014-06-09
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of the study is to evaluate the single-dose pharmacokinetics (PK) of velpatasvir (formerly GS-5816) in participants with severe renal impairment using matched healthy participants as a control group.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Velpatasvir

Criteria

Key Inclusion Criteria:

• General good health with stable chronic kidney disease in Severe Renal Impairment Group

• Screening labs within defined thresholds

• Creatinine clearance must be < 30 mL/min for Severe Renal Impairment group, and ≥ 90 mL/min for Normal Renal Function group

Key Exclusion Criteria:

• Females who are pregnant or nursing, or males who have a pregnant partner

• Infection with hepatitis B virus (HBV), hepatitis C virus (HCV) or HIV

• History of clinically significant illness (including psychiatric or cardiac) or any other medical disorder that may interfere with participant treatment and/or adherence to the protocol

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