NCT02400307

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 19 (actual)
• Sponsor: Gilead Sciences · Industry
• Sex: All
• Age: 18 Years – 79 Years
• Healthy volunteers: Accepted

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.

Conditions

• HIV

Interventions

Type	Name	Description
DRUG	Bictegravir	75 mg tablet administered orally

Timeline

• Start date: 2015-04-17
• Primary completion: 2015-07-06
• Completion: 2015-07-13
• First posted: 2015-03-27
• Last updated: 2019-10-11
• Results posted: 2019-10-11

Locations

7 sites across 2 countries: United States, New Zealand

Regulatory

• FDA-regulated drug study