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Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

Primary Purpose

HIV

Status

Completed

Phase

Phase 1

Locations

International

Study Type

Interventional

Intervention

Bictegravir

About this trial

This is an interventional treatment trial for HIV focused on measuring Phase 1, Renally Impaired

Eligibility Criteria

18 Years - 79 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Avail Clinical Research
Clinical Pharmacology of Miami, Inc.
Orlando Clinical Research Center
Prism Clinical Research
New Orleans Center for Clinical Research
Auckland Clinical Studies Limited
Christchurch Clinical Studies Trust

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

Severe Renal Impairment

Moderate Renal Impairment

Mild Renal Impairment

Arm Description

Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir.

Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir.

Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir.

Outcomes

Primary Outcome Measures

Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)

AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.

PK Parameter: AUCinf of Bictegravir (Free)

Free AUCinf was calculated based on unbound plasma bictegravir (AUCinf × percentage unbound bictegravir ÷ 100 for each participant).

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.

PK Parameter: AUClast of Bictegravir (Free)

Free AUClast was calculated based on unbound plasma bictegravir (AUClast × percentage unbound bictegravir ÷ 100 for each participant).

PK Parameter: Cmax of Bictegravir (Total)

Cmax is defined as the maximum observed plasma concentration of drug.

PK Parameter: Cmax of Bictegravir (Free)

Free Cmax was calculated based on unbound plasma bictegravir (Cmax × percentage unbound bictegravir ÷ 100 for each participant).

Secondary Outcome Measures

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.

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.

Full Information

NCT ID

NCT02400307

First Posted

March 17, 2015

Last Updated

September 20, 2019

Sponsor

Gilead Sciences

1. Study Identification

Unique Protocol Identification Number

NCT02400307

Brief Title

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

2. Study Status

Record Verification Date

September 2019

Overall Recruitment Status

Completed

Study Start Date

April 17, 2015 (Actual)

Primary Completion Date

July 6, 2015 (Actual)

Study Completion Date

July 13, 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

HIV

Keywords

Phase 1, Renally Impaired

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

19 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Severe Renal Impairment

Arm Type

Experimental

Arm Description

Participants with severe renal impairment and matched healthy controls will receive a single dose of bictegravir.

Arm Title

Moderate Renal Impairment

Arm Type

Experimental

Arm Description

Participants with moderate renal impairment and matched healthy controls will receive a single dose of bictegravir.

Arm Title

Mild Renal Impairment

Arm Type

Experimental

Arm Description

Participants with mild renal impairment and matched healthy controls will receive a single dose of bictegravir.

Intervention Type

Drug

Intervention Name(s)

Bictegravir

Other Intervention Name(s)

GS-9883

Intervention Description

75 mg tablet administered orally

Primary Outcome Measure Information:

Title

Pharmacokinetic (PK) Parameter: AUCinf of Bictegravir (Total)

Description

AUCinf is defined as the area under the plasma concentration versus time curve extrapolated to infinite time.

Time Frame