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A Two-Part Open-Label, Single-Centre Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects

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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

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At a glance

  • Drugs Darolutamide (Primary) ; Darolutamide (Primary)
  • Indications Male breast cancer; Prostate cancer
  • Focus Pharmacokinetics
  • Acronyms ARIADME
  • Sponsors Orion

Most Recent Events

  • 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.

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