Mass Balance, Pharmacokinetics, Biotransformation and Bioavailability Study of ODM-201 in Healthy Male Subjects

Phase 1 Completed 12 enrolled Orion Corporation, Orion Pharma Bayer · collab

Non-randomizedParallel-groupOpen-labelBasic science

Summary

A study to investigate absolute bioavailability of ODM-201 and to determine the mass balance and routes of excretion of ODM-201 in healthy volunteers.

Timeline

Start: 2015-03
Primary completion: 2015-05
Completion: 2015-06

Publications

Zurth C, Nykanen P, Wilkinson G, Taavitsainen P, Vuorela A, Huang F, Reschke S, Koskinen M. Clinical Pharmacokinetics of the Androgen Receptor Inhibitor Darolutamide in Healthy Subjects and Patients with Hepatic or Renal Impairment. Clin Pharmacokinet. 2022 Apr;61(4):565-575. doi: 10.1007/s40262-021-01078-y. Epub 2021 Dec 6.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Darolutamide	Other / unclassified	100 ug	Oral
Subject	Darolutamide	Other / unclassified	300 mg	Oral

Indications

No indication recorded.