Trial Profile

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

Status: Completed

Phase of Trial: Phase I

Latest Information Update: 21 Feb 2024

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At a glance

Drugs Pexidartinib (Primary)
Indications Acral lentiginous melanoma; Acute myeloid leukaemia; Breast cancer; Gastrointestinal stromal tumours; Giant cell tumour of tendon sheath; Glioblastoma; Leukaemia; Malignant melanoma; Prostate cancer; Sarcoma; Solid tumours
Focus Pharmacokinetics
Sponsors Daiichi Sankyo Inc

05 Mar 2022 Results of an analysis of two open label phase I studies assessing the effect of mild and moderate hepatic impairment on Pexidartinib pharmacokinetics published in the Journal of Clinical Pharmacology
17 Sep 2021 Results assessing effect of moderate hepatic impairment on pexidartinib pharmacokinetics, presented at the 2021 American College of Clinical Pharmacology Annual Meeting.
08 Oct 2020 Status changed from recruiting to completed.

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