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

Gilead Sciences20 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Hepatitis B Virus

Interventions

TAFDRUG

25 mg tablet administered orally

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (5)

Unnamed facility

Miami, Florida, United States

Unnamed facility

Orlando, Florida, United States

Unnamed facility

San Antonio, Texas, United States

Unnamed facility

Munich, Germany

Unnamed facility

Gratton, Auckland, New Zealand

Outcomes

Primary Outcomes

Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF

AUCinf is defined as the concentration of drug extrapolated to infinite time.

Time frame: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1

PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF

Cmax is defined as the maximum concentration of drug.

Time frame: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1

PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF

AUClast is defined as the concentration of drug from time zero to the last observable concentration.

Time frame: Predose (≤5 minutes), 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4, 5, 8, 12, 24, 36, 48, 60, 72, 96, 120, and 144 hours postdose on Day 1

Secondary Outcomes

Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)

TEAEs are events that meet one of the following criteria: any AEs with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.

Time frame: Day 1 plus 30 days

Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities

Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. These were graded as Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening. The most severe graded abnormality from all tests was counted for each participant.

Time frame: Day 1 plus 30 days

Data from ClinicalTrials.gov

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