Phase 1 ADME study in healthy male volunteers (QSC200301)
Research type
Research Study
Full title
A phase 1 open-label, single-dose study designed to assess the mass balance recovery and metabolite profile and to identify metabolite structures for [14C]-CORT125281 in healthy subjects
IRAS ID
246868
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2018-001700-11
Duration of Study in the UK
0 years, 1 months, 5 days
Research summary
The Sponsor is developing the study drug, CORT125281, for the potential treatment of castration-resistant prostate cancer (CRPC). Prostate cancer is the most common cancer diagnosed amongst men. Treatment options include surgery or administration of medicines to reduce the amount of hormones (for example testosterone) which prevents the cancer progressing. However some forms of prostate cancer progress despite the treatments mentioned above, these forms are called CRPC.
The study will try to evaluate how much of the test medicine, [14C]-CORT125281, is taken up, distributed, broken down and removed from the body when given by mouth.
This is an open-label, single dose study in up to 6 healthy male volunteers. Volunteers will attend the clinical unit on one occasion to receive one dose of 360 mg of the study drug as 6 capsules to swallow. Volunteers will remain in the clinical unit until 8 days post-dose, when the subjects will be discharged as a group if the discharge criteria are met. If the discharge criteria are not met by Day 8, volunteers may remain in the clinical unit for up to 2 additional 24 hour periods (up to Day 10).
REC name
Wales REC 2
REC reference
18/WA/0252
Date of REC Opinion
24 Aug 2018
REC opinion
Further Information Favourable Opinion