Study to Evaluate the Pharmacokinetics of Tenofovir Alafenamide (TAF) in Adults With Normal Hepatic Function and Adults With Severe Hepatic Impairment

Hepatitis B Virus Clinical Trial

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

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
• 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
• 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.

Related Conditions & MeSH terms

• Hepatitis B
• Hepatitis B Virus

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