drugset / Trial / NCT02400307

Pharmacokinetics of Bictegravir in Adults With Normal and Impaired Renal Function

NCT02400307

Phase 1 Completed 19 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2015-04-17
Primary completion
2015-07-06
Completion
2015-07-13

Drugs

EvaluationDrugModalityDoseRoute
Subject bictegravir Small molecule 75 mg Oral