Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

• Status: Completed
• Trial end date: 2015-07-13
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Gilead Sciences

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.