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A Phase 1, Open Label, Fixed-sequence Study to Evaluate the Effect of BAY1841788 (ODM-201) on Drug Transporters Using Rosuvastatin as Probe Substrate and to Assess Pharmacokinetics and Safety of BAY1841788 in Female and Male Volunteers

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Trial Profile

A Phase 1, Open Label, Fixed-sequence Study to Evaluate the Effect of BAY1841788 (ODM-201) on Drug Transporters Using Rosuvastatin as Probe Substrate and to Assess Pharmacokinetics and Safety of BAY1841788 in Female and Male Volunteers

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Dec 2021

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At a glance

  • Drugs Darolutamide (Primary) ; Rosuvastatin
  • Indications Breast cancer; Prostate cancer
  • Focus Pharmacokinetics
  • Sponsors Bayer

    • Most Recent Events

    • 06 Dec 2021 Results of pooled analysis from NCT02418650, NCT02894385, NCT02671097; analysing pharmacokinetic profile of darolutamide, its diastereomers, and its main active metabolite, keto-darolutamide, published in the Clinical Pharmacokinetics
    • 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
    • 07 Sep 2016 Status changed from active, no longer recruiting to completed.
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