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

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

Most Recent Events

  • 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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