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A Phase 1, Open-Label, Randomized, 3-Period Crossover Study to Assess the Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Subjects

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Trial Profile

A Phase 1, Open-Label, Randomized, 3-Period Crossover Study to Assess the Effect of Low-Fat Food on Pexidartinib Pharmacokinetics in Healthy Subjects

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 20 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

  • 17 Sep 2021 Results presented at the 2021 American College of Clinical Pharmacology Annual Meeting
  • 23 Sep 2020 Results assessing effect of food (i.e., high- or low-fat meal) on pexidartinib pharmacokinetics (PK) in healthy subjects in 4 studies, presented at the 2020 American College of Clinical Pharmacology Annual Meeting.
  • 24 Jun 2019 Status changed from active, no longer recruiting to completed.

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