Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants

Phase 0 Completed 16 enrolled Daiichi Sankyo

Non-randomizedParallel-groupSingle-blindTreatment

Summary

The pharmacokinetics of a single dose of pexidartinib was investigated in participants with impaired hepatic function and compared with healthy control participants with normal hepatic function.

Timeline

Start: 2020-01-07
Primary completion: 2020-10-02
Completion: 2020-10-02

Publications

Zahir H, Greenberg J, Hsu C, Marbury TC, Lasseter KC, Xu LA, Tap WD, Healey JH, Stacchiotti S, LaCreta F. Effect of Mild and Moderate Hepatic Impairment (Defined by Child-Pugh Classification and National Cancer Institute Organ Dysfunction Working Group Criteria) on Pexidartinib Pharmacokinetics. J Clin Pharmacol. 2022 Aug;62(8):992-1005. doi: 10.1002/jcph.2042. Epub 2022 Mar 31.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Pexidartinib	Small molecule	200 mg	Oral

Indications

No indication recorded.