Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

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

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.

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.