Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment

• Status: Completed
• Trial end date: 2015-04-17
• Target enrollment: 0
• Participant gender: All

Summary

The primary objective of this study is to evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and its metabolite tenofovir (TFV) in participants with normal hepatic function and in participants with severe hepatic impairment.

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

Details

• Lead Sponsor: Gilead Sciences
• Treatments: Tenofovir

Criteria

Key Inclusion Criteria:

• Screening laboratory parameters within defined thresholds

• Creatinine clearance must be ≥ 60 mL/min

Key Exclusion Criteria:

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

• Infection with hepatitis B virus (HBV) 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.