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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02296853
Other study ID # GS-US-320-1615
Secondary ID 2014-004426-18
Status Completed
Phase Phase 1
First received
Last updated
Start date December 22, 2014
Est. completion date April 17, 2015

Study information

Verified date November 2020
Source Gilead Sciences
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 20
Est. completion date April 17, 2015
Est. primary completion date April 17, 2015
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 70 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
TAF
25 mg tablet administered orally

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Germany,  New Zealand, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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 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. Day 1 plus 30 days
Secondary 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. Day 1 plus 30 days
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