NCT02296853

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

A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis B Virus

Interventions

Type	Name	Description
DRUG	TAF	25 mg tablet administered orally

Timeline

• Start date: 2014-12-22
• Primary completion: 2015-04-17
• Completion: 2015-04-17
• First posted: 2014-11-20
• Last updated: 2020-12-09
• Results posted: 2020-12-09

Locations

5 sites across 3 countries: United States, Germany, New Zealand

Regulatory

• FDA-regulated drug study