Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

19 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-17

Study Completion Date

2015-07-13

Brief Summary

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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.

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Detailed Description

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Conditions

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HIV

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Severe Renal Impairment

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

75 mg tablet administered orally

Moderate Renal Impairment

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

75 mg tablet administered orally

Mild Renal Impairment

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

Group Type EXPERIMENTAL

Bictegravir

Intervention Type DRUG

75 mg tablet administered orally

Interventions

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Bictegravir

75 mg tablet administered orally

Intervention Type DRUG

Other Intervention Names

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GS-9883

Eligibility Criteria

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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

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

79 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes