Status:
COMPLETED
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Lead Sponsor:
Gilead Sciences
Conditions:
Hepatitis B Virus
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief 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 i...
Eligibility Criteria
Inclusion
- Key
- Screening laboratory parameters within defined thresholds
- Creatinine clearance must be ≥ 60 mL/min
- Key
Exclusion
- 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.
Key Trial Info
Start Date :
December 22 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 17 2015
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT02296853
Start Date
December 22 2014
End Date
April 17 2015
Last Update
December 9 2020
Active Locations (5)
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1
Miami, Florida, United States, 33014
2
Orlando, Florida, United States, 32809
3
San Antonio, Texas, United States, 78215
4
Munich, Germany, D-81241