The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT02296853




Registration number
NCT02296853
Ethics application status
Date submitted
18/11/2014
Date registered
20/11/2014
Date last updated
23/10/2018

Titles & IDs
Public title
Pharmacokinetics of Tenofovir Alafenamide in Adults With Normal Hepatic Function and Severe Hepatic Impairment
Scientific title
A Phase 1, Open-Label, Parallel-Group, Single Dose Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Subjects With Normal Hepatic Function and Subjects With Severe Hepatic Impairment
Secondary ID [1] 0 0
2014-004426-18
Secondary ID [2] 0 0
GS-US-320-1615
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Hepatitis B Virus 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Oral and Gastrointestinal 0 0 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Cancer 0 0 0 0
Liver

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - TAF

Experimental: TAF - Severe Hepatic Impairment - Participants with severe hepatic impairment will receive a single dose of TAF.

Active Comparator: TAF - Normal Hepatic Function - Participants with normal hepatic function will receive a single dose of TAF.


Treatment: Drugs: TAF
Tenofovir alafenamide (TAF) 25 mg tablet administered orally

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Plasma pharmacokinetics (PK) profiles of TAF and TFV: AUClast, AUCinf, and Cmax - This composite endpoint will measure the plasma PK profiles of TAF and TFV. PK parameters that will be measured include AUClast, AUCinf, and Cmax.
Timepoint [1] 0 0
Predose and postdose on Day 1
Secondary outcome [1] 0 0
Incidences of adverse events and graded laboratory abnormalities
Timepoint [1] 0 0
Up to 31 days

Eligibility
Key inclusion criteria
- Screening labs within defined thresholds

- Creatinine clearance must be = 60 mL/min
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
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

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Florida
Country [2] 0 0
United States of America
State/province [2] 0 0
Texas
Country [3] 0 0
Germany
State/province [3] 0 0
Munich
Country [4] 0 0
New Zealand
State/province [4] 0 0
Auckland

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Gilead Sciences
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
This study will evaluate the single-dose pharmacokinetics of tenofovir alafenamide (TAF) and
it's metabolite tenofovir (TFV) along with the safety and tolerability of TAF in participants
with normal hepatic function and severe hepatic impairment.
Trial website
https://clinicaltrials.gov/show/NCT02296853
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
John F Flaherty, Pharm. D.
Address 0 0
Gilead Sciences
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications