Pharmacokinetics of Tenofovir Alafenamide in Adults With Normal Hepatic Function and Severe Hepatic Impairment
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Hepatitis |
| Therapuetic Areas: | Gastroenterology, Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 10/25/2018 |
| Start Date: | December 2014 |
| End Date: | April 2015 |
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
This study will evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and
it's metabolite tenofovir (TFV) along with the safety and tolerability of TAF in participants
with normal hepatic function and severe hepatic impairment.
it's metabolite tenofovir (TFV) along with the safety and tolerability of TAF in participants
with normal hepatic function and severe hepatic impairment.
Inclusion Criteria:
- Screening labs within defined thresholds
- Creatinine clearance must be ≥ 60 mL/min
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
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