Clinical trial NCT02400307: Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV
Keywords: Phase 1
Renally Impaired
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2015-03-27
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Maximum age (years): 79
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)
timeFrame: 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
measure: PK Parameter: AUCinf of Bictegravir (Free)
timeFrame: 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
measure: PK Parameter: AUClast of Bictegravir (Total)
timeFrame: 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
measure: PK Parameter: AUClast of Bictegravir (Free)
timeFrame: 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
measure: PK Parameter: Cmax of Bictegravir (Total)
timeFrame: 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
measure: PK Parameter: Cmax of Bictegravir (Free)
timeFrame: 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 outcomes:
measure: Percentage of Participants Who Experienced Treatment-Emergent Adverse Events
timeFrame: First dose date to Day 31
measure: Percentage of Participants Who Experienced Treatment-Emergent Laboratory Abnormalities
timeFrame: First dose date to Day 31
Other outcomes:
Locations:
city: DeLand
country: United States
facility: Avail Clinical Research
state: Florida
city: Miami
country: United States
facility: Clinical Pharmacology of Miami, Inc.
state: Florida
city: Orlando
country: United States
facility: Orlando Clinical Research Center
state: Florida
city: Saint Paul
country: United States
facility: Prism Clinical Research
state: Minnesota
city: Knoxville
country: United States
facility: New Orleans Center for Clinical Research
state: Tennessee
city: Grafton
country: New Zealand
facility: Auckland Clinical Studies Limited
state: Auckland
city: Christchurch
country: New Zealand
facility: Christchurch Clinical Studies Trust
Study officials:
affiliation: Gilead Sciences
name: Gilead Study Director
role: STUDY_DIRECTOR
References: