drugset / Trial / NCT02959138

Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function

NCT02959138

Phase 1 Completed 36 enrolled Gilead Sciences
Non-randomizedParallel-groupOpen-labelTreatment

Summary

The primary objective of this study is to evaluate the pharmacokinetics (PK) of lanraplenib in participants with impaired renal function relative to matched healthy controls. Participants in this study will be enrolled using an adaptive design that includes up to 3 enrolled cohorts. Based on safety and/or PK data in Cohort 1, participants will be enrolled in adaptive Cohorts 2 and/or 3.

Timeline

Start
2016-11-21
Primary completion
2018-10-05
Completion
2018-10-05

Publications

  • Background Hsueh CH, Zheng H, Matzkies F, Mozaffarian A, Medzihradsky O, Tarnowski T, Curry N, and Mathias A. Pharmacokinetics and Short-Term Safety of GS-9876, an Oral Spleen Tyrosine Kinase Inhibitor in Subjects with Renal Impairment. American Society for Clinical Pharmacology and Therapeutics 2019; Washington D.C.

Drugs

EvaluationDrugModalityDoseRoute
Subject Lanraplenib Small molecule 20 mg Oral

Indications