Spots Global Cancer Trial Database for Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants

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Trial Identification

Brief Title: Study of Pexidartinib in Participants With Moderate Hepatic Impairment Compared With Healthy Participants

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

Study ID: NCT04223635

Conditions

Moderate Hepatic Impairment

Interventions

Pexidartinib

Study Description

Brief 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.

Detailed 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.