Trial Profile
A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects
Status:
Completed
Phase of Trial:
Phase I
Latest Information Update: 10 Dec 2021
Price :
$35
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At a glance
- Drugs Darolutamide (Primary) ; Darolutamide (Primary)
- Indications Male breast cancer; Prostate cancer
- Focus Pharmacokinetics
- Acronyms ARIADME
- Sponsors Orion
- 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
- 30 Mar 2021 Results of part 2 (n=6) assessing absorption, metabolism, routes of excretion, and mass balance of darolutamide as an oral solution, published in the Drug Metabolism and Disposition
- 22 Jun 2015 Status changed from recruiting to completed as reported by ClinicalTrials.gov.