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
Latest Information Update: 10 Dec 2021
At a glance
- Drugs Darolutamide (Primary)
- Indications Liver cirrhosis; Renal impairment
- Focus Pharmacokinetics
- Sponsors Bayer
- 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.