At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 20 enrolled
Drug / intervention
TAFdrug
Likely dose
TAF 25 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 1 clinical trial evaluating TAF for Hepatitis B Virus. Completed, enrolled 20 participants across 5 sites in 3 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHepatitis B Virus
CountriesGermany, New Zealand, United States
Collaborators--
Timeline
Phase 1CompletedFinished
201520162017201820192020202120222023202420252026
First PostedNov 2014
Enrollment StartDec 2014
Primary CompletionApr 2015
TodayJul 2026
First PostedNov 20, 2014
Enrollment StartDec 22, 2014
Primary CompletionApr 17, 2015
TodayJul 2, 2026
Enrollment to primary: 4 monthsPosted 11.6 years ago
Interventions
TAFdrug
25 mg tablet administered orally