A Phase I, Non-randomized, Open-label, Fixed-sequence Study to Investigate the Effect of Darolutamide (ODM-201) on the Pharmacokinetics of a Probe Substrate of CYP3A4 and P-gp in Healthy Male Volunteers
Phase of Trial: Phase I
Latest Information Update: 27 Dec 2017
At a glance
- Drugs Darolutamide (Primary) ; Dabigatran etexilate; Midazolam
- Indications Prostate cancer
- Focus Pharmacokinetics
- Sponsors Bayer
- 20 Dec 2017 Status changed from active, no longer recruiting to completed.
- 13 Dec 2017 Planned End Date changed from 15 Nov 2017 to 15 Dec 2017.
- 09 Nov 2017 Planned End Date changed from 20 Oct 2017 to 15 Nov 2017.