drugset / Trial / NCT02959138
Pharmacokinetics of Lanraplenib in Adults With Impaired Renal Function
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Lanraplenib | Small molecule | 20 mg | Oral |