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

Moderate Hepatic Impairment Clinical Trial

Official title:
An Open-label, Single-dose Study to Assess the Pharmacokinetics of Pexidartinib in Subjects With Moderate Hepatic Impairment Compared to Healthy Subjects

Status Completed

Clinical Trial 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.

Clinical Trial Description

Pexidartinib is an orally administered tyrosine kinase inhibitor, currently approved in the US for the treatment of adult patients with symptomatic tenosynovial giant cell tumor (TGCT) associated with severe morbidity or functional limitations and not amenable to improvement with surgery. The primary objective of this study is to determine the plasma pharmacokinetics (PK) of pexidartinib after a single oral dose of 200 mg in participants with moderate hepatic impairment (HI) as defined by National Cancer Institute Organ Dysfunction Working Group (NCI-ODWG) criteria compared to the healthy controls participants with normal hepatic function. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04223635
Study type	Interventional
Source	Daiichi Sankyo, Inc.
Contact
Status	Completed
Phase	Early Phase 1
Start date	January 7, 2020
Completion date	October 2, 2020

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