Bioavailability of ODM-201 ADME & IV Microtracer Study (QBR116252)
Research type
Research Study
Full title
A Two-Part, Open-Label, Single-Centre, Mass Balance, Pharmacokinetics, Biotransformation and Absolute Bioavailability Study of ODM-201 in Healthy Male Subjects
IRAS ID
169894
Contact name
Ulla Sairanen
Contact email
Sponsor organisation
Orion Corporation Orion Pharma
Eudract number
2013-002061-19
Duration of Study in the UK
0 years, 1 months, 8 days
Research summary
The Sponsor is developing the study drug, ODM-201, for the potential treatment of an advanced form of prostate cancer known as castration-resistant prostate cancer (CRPC).
The study will consist of two parts involving up to 12 healthy male subjects. Part 1 of the study will investigate how the study drug is taken up and broken down by the body when given orally (by mouth) and when given as a radiolabelled (14C) injection directly into the vein.
Part 2 of the study will investigate a radiolabelled (14C) oral dose of ODM-201, to measure how the drug is absorbed, broken down and removed from the body.
The safety and tolerability of the drug will also be assessed during both parts of the study.REC name
Wales REC 2
REC reference
15/WA/0045
Date of REC Opinion
20 Feb 2015
REC opinion
Further Information Favourable Opinion