Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

HIV Clinical Trial

Official title:

A Phase 1, Open-Label, Parallel-Group, Adaptive Single-dose Study to Evaluate the Pharmacokinetics of GS-9883 in Subjects With Normal and Impaired Renal Function

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02400307
• Other study ID #: GS-US-141-1479
• Secondary ID: 2015-000898-12
• Status: Completed
• Phase: Phase 1
• Start date: April 17, 2015
• Est. completion date: July 13, 2015

Study information

• Verified date: September 2019
• 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 pharmacokinetic (PK) profile of oral bictegravir (formerly GS-9883) in adults with impaired renal function relative to matched, healthy controls with normal renal function. Each participant in the renal impairment groups will be matched for age (± 10 years), gender, and body mass index [BMI (± 20%, 18 ≤ BMI ≤ 40 kg/m^2)] with a participant in the control group.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 19
• Est. completion date: July 13, 2015
• Est. primary completion date: July 6, 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 79 Years

Eligibility

Key Inclusion Criteria:

• All Individuals:

• Must have a calculated BMI from 18 to 40 kg/m^2, inclusive, at screening

• Individuals with impaired renal function

• Chronic stable renal impairment without recent clinical change

• Mild: Creatinine clearance (CrCl) = 60 - 89 mL/min

• Moderate: CrCl = 30 - 59 mL/min

• Severe: CrCl = 15 - 29 mL/min

• Healthy individuals

• CrCl = 90 mL/min

Key Exclusion Criteria:

• All Individuals:

• Pregnant or lactating females

• HIV positive or chronic hepatitis B infected

• Individuals with impaired renal function

• Chronic liver disease

• Dialysis or anticipated use of dialysis

• Renal transplant

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

Related Conditions & MeSH terms

• HIV
• Renal Insufficiency

Intervention

Drug:
• Bictegravir
75 mg tablet administered orally

Locations

Country	Name	City	State
New Zealand	Christchurch Clinical Studies Trust	Christchurch
New Zealand	Auckland Clinical Studies Limited	Grafton	Auckland
United States	Avail Clinical Research	DeLand	Florida
United States	New Orleans Center for Clinical Research	Knoxville	Tennessee
United States	Clinical Pharmacology of Miami, Inc.	Miami	Florida
United States	Orlando Clinical Research Center	Orlando	Florida
United States	Prism Clinical Research	Saint Paul	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  New Zealand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)	AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary	PK Parameter: AUCinf of Bictegravir (Free)	Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary	PK Parameter: AUClast of Bictegravir (Total)	AUClast is defined as the area under the plasma concentration versus time curve from time zero to the last quantifiable concentration.	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary	PK Parameter: AUClast of Bictegravir (Free)	Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary	PK Parameter: Cmax of Bictegravir (Total)	Cmax is defined as the maximum observed plasma concentration of drug.	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Primary	PK Parameter: Cmax of Bictegravir (Free)	Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).	Predose and 0.5, 1, 2, 3, 4, 6, 8, 12, 18, 24, 36, 48, 72, 96, 120 and 144 hours postdose on Day 1
Secondary	Percentage of Participants Who Experienced Treatment-Emergent Adverse Events	Treatment-emergent adverse events (TEAEs) are defined as any adverse events (AEs) with an onset date 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.	First dose date to Day 31
Secondary	Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities	A treatment-emergent graded laboratory abnormality was defined as an increase of at least 1 abnormality grade from the predose assessment and occurring after the predose visit and on or before the date of the administration of study drug plus 30 days. The most severe graded abnormality from all tests was counted for each participant. Toxicity grade was defined as follows: Grade 1 = Mild, Grade 2 = Moderate, Grade 3 = Severe, and Grade 4 = Life-threatening.	First dose date to Day 31