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
Phase of Trial: Phase I
Latest Information Update: 02 Aug 2017
At a glance
- Drugs Darolutamide (Primary)
- Indications Liver cirrhosis; Renal impairment
- Focus Pharmacokinetics
- Sponsors Bayer
- 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.
- 15 May 2017 Planned End Date changed from 16 Jun 2017 to 14 May 2018.