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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02296853




Registration number
NCT02296853
Ethics application status
Date submitted
18/11/2014
Date registered
20/11/2014
Date last updated
9/12/2020

Titles & IDs
Public title
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With 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

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

Experimental: Severe Hepatic Impairment Group - Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1.

Active Comparator: Matched Normal Hepatic Function Group - Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1.


Treatment: Drugs: TAF
25 mg tablet administered orally
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF
Timepoint [1] 0 0
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
Primary outcome [2] 0 0
PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF
Timepoint [2] 0 0
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
Primary outcome [3] 0 0
PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF
Timepoint [3] 0 0
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 outcome [1] 0 0
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Timepoint [1] 0 0
Day 1 plus 30 days
Secondary outcome [2] 0 0
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities
Timepoint [2] 0 0
Day 1 plus 30 days

Eligibility
Key inclusion criteria
Key

- Screening laboratory parameters within defined thresholds

- Creatinine clearance must be = 60 mL/min

Key
Minimum age
18 Years
Maximum age
70 Years
Sex
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

NOTE: Other protocol defined Inclusion/ Exclusion criteria may apply.

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
22/12/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
17/04/2015
Sample size
Target
Accrual to date
Final
20
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
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 website
https://clinicaltrials.gov/ct2/show/NCT02296853
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Gilead Study Director
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02296853