[14C]-CORT125134 in Healthy Subjects QCL117667
Research type
Research Study
Full title
An Open-Label, Single-Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Identification of Metabolite Structures for [14C]-CORT125134 in Healthy Subjects
IRAS ID
201451
Contact name
Hazel Hunt
Sponsor organisation
Corcept Therapeutics
Eudract number
2016-000668-41
Clinicaltrials.gov Identifier
Duration of Study in the UK
0 years, 1 months, 1 days
Research summary
The Sponsor is developing the study drug, CORT125134, for the potential treatment of Cushing’s syndrome and cancer. Cushing’s syndrome is a condition which is caused by excessive amounts of a hormone called cortisol in the body.Symptoms include weight gain especially around the body and face, moodiness, irritability or depression, reddening of the face and neck, excess sweating, excess growth of body and facial hair, raised blood pressure, loss of minerals from the bones, raised blood glucose levels, baldness, lowered memory and attention span, impotence, infertility and insomnia.\n\nThe study will try to identify how radiolabelled CORT125134 is taken up, broken down and removed from the body when given as an oral capsule (by mouth). Radiolabelled means that the test drug has a radioactive component which helps researchers to track where the drug is as it moves through and out of the body. \n\nThe is a single period study involving up to 10 healthy male and female subjects. Each subject will receive a single dose of 250 mg study drug on one occasion. The study visit may last up to 8 days with 8 overnight stays. Blood, urine and faecal samples will be taken from pre-dose to day 8\n
REC name
London - Riverside Research Ethics Committee
REC reference
16/LO/0989
Date of REC Opinion
20 Jun 2016
REC opinion
Favourable Opinion