Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

Gilead Sciences

Status and phase: Completed; Phase 1

Conditions: HIV

Treatments: Drug: Bictegravir

Study type: Interventional

Funder types: Industry

Identifiers

NCT02400307

2015-000898-12 (EudraCT Number)

GS-US-141-1479

Details and patient eligibility

About

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.

Enrollment: 19 patients

Sex: All

Ages: 18 to 79 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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19 participants in 3 patient groups

Severe Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Bictegravir

Moderate Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Bictegravir

Mild Renal Impairment

Experimental group

Description:

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

Treatment:

Drug: Bictegravir