NCT02296853

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at P25-P50 for phase_1

Timeline
Completed

Started Dec 2014

Shorter than P25 for phase_1

Geographic Reach
3 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 18, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

December 22, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 17, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 17, 2015

Completed
5.7 years until next milestone

Results Posted

Study results publicly available

December 9, 2020

Completed
Last Updated

December 9, 2020

Status Verified

November 1, 2020

Enrollment Period

4 months

First QC Date

November 18, 2014

Results QC Date

November 12, 2020

Last Update Submit

November 12, 2020

Conditions

Hepatitis B Virus

Keywords

Severe Hepatic Impairment

Outcome Measures

Primary Outcomes (3)

  • 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.

    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.

    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.

    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 (2)

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

    Day 1 plus 30 days

  • Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities

    Day 1 plus 30 days

Study Arms (2)

Severe Hepatic Impairment Group

EXPERIMENTAL

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

Drug: TAF

Matched Normal Hepatic Function Group

ACTIVE COMPARATOR

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

Drug: TAF

Interventions

TAFDRUG

25 mg tablet administered orally

Matched Normal Hepatic Function GroupSevere Hepatic Impairment Group

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Screening laboratory parameters within defined thresholds
  • Creatinine clearance must be ≥ 60 mL/min

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Miami, Florida, 33014, United States

Location

Unknown Facility

Orlando, Florida, 32809, United States

Location

Unknown Facility

San Antonio, Texas, 78215, United States

Location

Unknown Facility

Munich, D-81241, Germany

Location

Unknown Facility

Gratton, Auckland, 1142, New Zealand

Location

MeSH Terms

Conditions

Hepatitis B

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Results Point of Contact

Title
Gilead Clinical Study Information Center
Organization
Gilead Sciences
GileadClinicalTrials@gilead.com
1-833-445-3230 (GILEAD-0)

Study Officials

  • Gilead Study Director

    Gilead Sciences

    STUDY DIRECTOR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 18, 2014

First Posted

November 20, 2014

Study Start

December 22, 2014

Primary Completion

April 17, 2015

Study Completion

April 17, 2015

Last Updated

December 9, 2020

Results First Posted

December 9, 2020

Record last verified: 2020-11

Data Sharing

IPD Sharing
Will share

Qualified external researchers may request IPD for this study after study completion. For more information, please visit our website at https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy

Shared Documents
STUDY PROTOCOL, SAP
Time Frame
18 months after study completion
Access Criteria
A secured external environment with username, password, and RSA code.
More information

Locations

US(3)NZ(1)DE(1)