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

NCT ID: NCT02296853

Last Updated: 2020-12-09

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-12-22

Study Completion Date

2015-04-17

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatitis B Virus

Keywords

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Severe Hepatic Impairment

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Severe Hepatic Impairment Group

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

Group Type EXPERIMENTAL

TAF

Intervention Type DRUG

25 mg tablet administered orally

Matched Normal Hepatic Function Group

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

Group Type ACTIVE_COMPARATOR

TAF

Intervention Type DRUG

25 mg tablet administered orally

Interventions

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TAF

25 mg tablet administered orally

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Screening laboratory parameters 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Gilead Sciences

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Gilead Study Director

Role: STUDY_DIRECTOR

Gilead Sciences

Locations

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Miami, Florida, United States

Site Status

Orlando, Florida, United States

Site Status

San Antonio, Texas, United States

Site Status

Munich, , Germany

Site Status

Gratton, Auckland, New Zealand

Site Status

Countries

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United States Germany New Zealand

Other Identifiers

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2014-004426-18

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

GS-US-320-1615

Identifier Type: -

Identifier Source: org_study_id