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A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function

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Trial Profile

A Phase I, Non-randomized, Open-label, Single-dose Study to Investigate the Pharmacokinetics, Safety and Tolerability of BAY 1841788 (ODM-201) in Male Subjects With Hepatic Impairment, Renal Impairment and Normal Hepatic and Renal Function

Status: Completed
Phase of Trial: Phase I

Latest Information Update: 10 Dec 2021

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At a glance

  • Drugs Darolutamide (Primary)
  • Indications Liver cirrhosis; Renal impairment
  • 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
    • 08 Jan 2018 Status changed from active, no longer recruiting to completed.
    • 29 Nov 2017 Status changed from recruiting to active, no longer recruiting.

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