Phase 1 N=20 Treatment

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

Hepatitis B Virus

Bottom Line

View on ClinicalTrials.gov: NCT02296853 ↗

Enrolled (actual)

Serious AEs

5.0%

Results posted

Dec 2020

Primary outcome: Primary: Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF — 120.6; 228.2; 219.9; 304.0 h*ng/mL

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: TAF (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Gilead Sciences
Primary completion: Apr 2015

Outcome Measures

Outcome	Result	p-value
PRIMARY Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF	120.6; 228.2; 219.9; 304.0; 42.8; 46.5	—
PRIMARY PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF	79.6; 176.0; 7.5; 7.6; 29.9; 36.2	—
PRIMARY PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF	113.1; 225.7; 184.2; 256.7; 41.7; 46	—
SECONDARY Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)	40.0; 30.0	—
SECONDARY Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities	40.0; 30.0; 40.0; 30.0; 20.0; 10.0	—

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.

Eligibility 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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02296853). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.