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A Phase 1, randomized study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ONC201 and the effects of food on the bioavailability of ONC201 following oral administration in healthy adult subjects

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Trial Profile

A Phase 1, randomized study to evaluate the safety, tolerability, and pharmacokinetics (PK) of ONC201 and the effects of food on the bioavailability of ONC201 following oral administration in healthy adult subjects

Status: Not yet recruiting
Phase of Trial: Phase I

Latest Information Update: 27 Oct 2023

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At a glance

  • Drugs Dordaviprone (Primary)
  • Indications Acute myeloid leukaemia; Adenocarcinoma; Breast cancer; Colorectal cancer; Endometrial cancer; Gallbladder cancer; Glioblastoma; Glioma; Liver cancer; Mantle-cell lymphoma; Multiple myeloma; Myelodysplastic syndromes; Neuroendocrine tumours; Non-Hodgkin's lymphoma; Pancreatic cancer; Precursor cell lymphoblastic leukaemia-lymphoma; Prostate cancer; Sarcoma; Small cell lung cancer; Solid tumours; Thyroid cancer
  • Focus Adverse reactions; Pharmacokinetics
  • Sponsors Chimerix

    • Most Recent Events

    • 12 Sep 2023 Results assessing the pharmacokinetics (PK) andsafety of dordaviprone when administered as cap-sule contents mixed with applesauce or dissolved inGatorade in comparison to the intact capsule presented at the 2023 American College of Clinical Pharmacology Annual Meeting
    • 29 Jul 2021 New trial record

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