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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
19
75 mg tablet administered orally
Avail Clinical Research
DeLand, Florida, 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, United States
Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)
AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.
Time frame: 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
PK Parameter: AUCinf of Bictegravir (Free)
Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).
Time frame: 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
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.
Time frame: 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
PK Parameter: AUClast of Bictegravir (Free)
Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).
Time frame: 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
PK Parameter: Cmax of Bictegravir (Total)
Cmax is defined as the maximum observed plasma concentration of drug.
Time frame: 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
PK Parameter: Cmax of Bictegravir (Free)
Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).
Time frame: 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
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New Orleans Center for Clinical Research
Knoxville, Tennessee, United States
Auckland Clinical Studies Limited
Grafton, Auckland, New Zealand
Christchurch Clinical Studies Trust
Christchurch, New Zealand
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.
Time frame: First dose date to Day 31
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.
Time frame: First dose date to Day 31