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

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

Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 04 Dec 2017

At a glance

  • Drugs Darolutamide (Primary)
  • Indications Liver cirrhosis; Renal impairment
  • Focus Pharmacokinetics
  • Sponsors Bayer
  • Most Recent Events

    • 29 Nov 2017 Status changed from recruiting to active, no longer recruiting.
    • 28 Jul 2017 Planned End Date changed from 3 May 2018 to 3 Dec 2018.
    • 28 Jul 2017 Planned primary completion date changed from 28 Feb 2018 to 28 Sep 2018.
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