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A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of Darolutamide (ODM-201) on the Pharmacokinetics of a Probe Substrate of CYP3A4 and P-gp in Healthy Male Volunteers

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Trial Profile

A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of Darolutamide (ODM-201) on the Pharmacokinetics of a Probe Substrate of CYP3A4 and P-gp in Healthy Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 05 Nov 2021

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At a glance

  • Drugs Darolutamide (Primary) ; Dabigatran etexilate; Midazolam
  • Indications Male breast cancer; Prostate cancer
  • Focus Pharmacokinetics
  • Sponsors Bayer

    • Most Recent Events

    • 30 Sep 2019 Results assessing drug-drug interaction potential of Darolutamide in invitro and invivo studies published in the European Journal of Drug Metabolism and Pharmacokinetics
    • 16 Feb 2019 Results assessing the drug-drug interactionof darolutamide with cytochrome P450 (CYP) and P-glycoprotein (P-gp) substrates in in-vito and in-vivo studies, presented at the 2019 Genitourinary Cancers Symposium
    • 20 Dec 2017 Status changed from active, no longer recruiting to completed.

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