A Study to Investigate the Effect of Hepatic Impairment on the Pharmacokinetics, Safety and Tolerability of ASP2215

Phase 1 Completed 24 enrolled Astellas Pharma Global Development, Inc.

Non-randomizedParallel-groupOpen-labelBasic science

Summary

The purpose of this study is to compare the single-dose pharmacokinetics of ASP2215 in subjects with mild and moderate hepatic impairment to matched healthy subjects with normal hepatic function. This study will also assess the safety and tolerability of single-dose ASP2215 in subjects with mild and moderate hepatic impairment and matched control subjects.

Timeline

Start: 2015-10-23
Primary completion: 2016-03-05
Completion: 2016-03-05

Publications

James AJ, Smith CC, Litzow M, Perl AE, Altman JK, Shepard D, Kadokura T, Souda K, Patton M, Lu Z, Liu C, Moy S, Levis MJ, Bahceci E. Pharmacokinetic Profile of Gilteritinib: A Novel FLT-3 Tyrosine Kinase Inhibitor. Clin Pharmacokinet. 2020 Oct;59(10):1273-1290. doi: 10.1007/s40262-020-00888-w.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Gilteritinib	Small molecule	—	Oral

Indications

No indication recorded.