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

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: Hepatitis B Virus

Treatments: Drug: TAF

Study type: Interventional

Funder types: Industry

Identifiers

NCT02296853

2014-004426-18 (EudraCT Number)

GS-US-320-1615

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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20 participants in 2 patient groups

Severe Hepatic Impairment Group

Experimental group

Description:

Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1.

Treatment:

Drug: TAF

Matched Normal Hepatic Function Group

Active Comparator group

Description:

Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1.

Treatment:

Drug: TAF