Absolute bioavailability study in healthy male subjects (QSC200300)
Research type
Research Study
Full title
An open-label, 2-part study designed to assess the absolute bioavailability of CORT118335 and determine the mass balance recovery, absorption, metabolism and elimination, and metabolite profile and identification of metabolite structures of [14C]-CORT118335 in healthy male subjects
IRAS ID
246594
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics
Eudract number
2018-001507-36
Duration of Study in the UK
0 years, 7 months, 22 days
Research summary
The Sponsor is developing the test medicine, CORT118335, for the potential treatment of non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). NAFLD and NASH includes a range of conditions caused by a build-up of fat in the liver. NAFLD may not cause any obvious signs of harm but can lead to a condition called Cirrhosis (scarring of the liver) which may lead to liver cancer and liver failure. NASH is a more serious form of NAFLD, where the liver has become inflamed.
This is a two part study, Part 1 will try to identify the level of study drug present in the blood and Part 2 will evaluate how the test medicine is taken up, distributed, broken down and removed from the body. For some of the doses in this study, the study drug will be radiolabelled to be analysed as it moves through the body. The safety and tolerability of the study drug will also be investigated.
The study will involve up to 12 healthy male volunteers. In Part 1, 6 volunteers will receive one dose of the study drug as a liquid to drink. Approximately 2 hours and 45 minutes after this dose, the volunteers will receive a second dose of the study drug, which will be radiolabelled, given intravenously (directly into the vein) over 15 minutes. Volunteers will remain in the clinical unit until Day 4 and will then attend a return visit on Days 6, 8 and 10. There will be a follow-up visit on Day 12. In Part 2 six volunteers who did not participate in Part 1 will be enrolled and receive one dose of the test medicine as a liquid to drink. The volunteers will be discharged once the discharge criteria are met.
REC name
London - Hampstead Research Ethics Committee
REC reference
18/LO/1231
Date of REC Opinion
24 Jul 2018
REC opinion
Further Information Favourable Opinion