Back to resultsStudy to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Primary Purpose
Hepatitis B Virus
Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
TAF
Sponsored by
About this trial
This is an interventional treatment trial for Hepatitis B Virus focused on measuring Severe Hepatic Impairment
Eligibility 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Severe Hepatic Impairment Group
Matched Normal Hepatic Function Group
Arm Description
Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1.
Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1.
Outcomes
Primary Outcome Measures
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.
PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF
Cmax is defined as the maximum concentration of drug.
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.
Secondary Outcome Measures
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
TEAEs are events that meet one of the following criteria: any AEs with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. These were graded as Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening. The most severe graded abnormality from all tests was counted for each participant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02296853
Brief Title
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
Official 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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Completed
Study Start Date
December 22, 2014 (Actual)
Primary Completion Date
April 17, 2015 (Actual)
Study Completion Date
April 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis B Virus
Keywords
Severe Hepatic Impairment
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Severe Hepatic Impairment Group
Arm Type
Experimental
Arm Description
Participants with severe hepatic impairment will receive a single oral dose of TAF 25 mg on Day 1.
Arm Title
Matched Normal Hepatic Function Group
Arm Type
Active Comparator
Arm Description
Participants with normal hepatic function will receive a single oral dose of TAF 25 mg on Day 1.
Intervention Type
Drug
Intervention Name(s)
TAF
Intervention Description
25 mg tablet administered orally
Primary Outcome Measure Information:
Title
Pharmacokinetic (PK) Parameter: AUCinf of Tenofovir Alafenamide (TAF), Its Metabolite Tenofovir (TFV) and Free (Unbound) TAF
Description
AUCinf is defined as the concentration of drug extrapolated to infinite time.
Time Frame
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
Title
PK Parameter: Cmax of TAF, Its Metabolite TFV and Free (Unbound) TAF
Description
Cmax is defined as the maximum concentration of drug.
Time Frame
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
Title
PK Parameter: AUClast of TAF, Its Metabolite TFV and Free (Unbound) TAF
Description
AUClast is defined as the concentration of drug from time zero to the last observable concentration.
Time Frame
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 Measure Information:
Title
Percentage of Participants Experiencing Treatment-Emergent Adverse Events (TEAEs)
Description
TEAEs are events that meet one of the following criteria: any AEs with onset date of on or after the study drug start date and no later than 30 days after permanent discontinuation of study drug or any AEs leading to premature discontinuation of study drug.
Time Frame
Day 1 plus 30 days
Title
Percentage of Participants Experiencing Treatment Emergent Laboratory Abnormalities
Description
Treatment-emergent laboratory abnormalities were defined as values that increase at least one toxicity grade from baseline. These were graded as Grade 1: mild, Grade 2: moderate, Grade 3: severe, Grade 4: life-threatening. The most severe graded abnormality from all tests was counted for each participant.
Time Frame
Day 1 plus 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
City
Miami
State/Province
Florida
ZIP/Postal Code
33014
Country
United States
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78215
Country
United States
City
Munich
ZIP/Postal Code
D-81241
Country
Germany
City
Gratton
State/Province
Auckland
ZIP/Postal Code
1142
Country
New Zealand
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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
IPD Sharing Time Frame
18 months after study completion
IPD Sharing Access Criteria
A secured external environment with username, password, and RSA code.
IPD Sharing URL
https://www.gilead.com/science-and-medicine/research/clinical-trials-transparency-and-data-sharing-policy
Learn more about this trial
Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment
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