ADME and PK Study of CORT125236 in Healthy Subjects (QSC301686)
Research type
Research Study
Full title
A Two-Part, Open-Label, Single-Dose Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-CORT125236 in Healthy Male Subjects and to Assess Pharmacokinetics of CORT125236 Tablet, Including Food Effect in Healthy Subjects
IRAS ID
1010259
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
ISRCTN Number
ISRCTN16855040
Research summary
The Sponsor is developing the test medicine as a potential treatment for solid tumours (cancer) in combination with chemotherapy or other cancer medicines. Solid tumours represent approximately 90% of adult human cancers. They can develop in many parts of the human body.
In Part 1, we’ll give volunteers a single dose of test medicine to find out how the body breaks down and gets rid of the test medicine. The test medicine will be ‘radiolabelled’ and contain a small amount of radioactivity (Carbon-14). In Part 2, we’ll compare blood levels of the test medicine after it's given in a new tablet form (recipe) with and without food and at two different dose levels.
In this study, we aim to answer these questions.
*How much test medicine enters the bloodstream and how quickly does the body get rid of it?
*Does food affect blood levels of the test medicine?
*How does the body break down and get rid of the test medicine?
We also want to get more information on the safety and tolerability of the test medicine and any side effects.This study will take place at 1 site in Nottingham. We plan to enrol 6 healthy men aged 30 to 65 years in Part 1 and 6 healthy men and women who are unable to have a baby, aged 18 to 55 years in Part 2. In Part 1, volunteers will receive a single dose of radiolabelled test medicine as capsules by mouth. They’ll stay in the clinic for up to 13 nights and take up to 6 weeks to finish the study. In Part 2, volunteers will receive 3 single doses of test medicine as tablets by mouth. They’ll stay in the clinic for 4 nights on 3 occasions, attend 3 return visits and 1 follow up visit, and take up to 9 weeks to finish the study.
We’ll collect samples to
*do safety tests (blood and urine)
*measure the amount of the test medicine (blood, Parts 1/2; urine and faeces, Part 1 only)
*measure the amount of radioactivity and breakdown products of the test medicine (blood, urine and faeces, Part 1 only)REC name
South Central - Berkshire Research Ethics Committee
REC reference
24/SC/0217
Date of REC Opinion
25 Sep 2024
REC opinion
Further Information Favourable Opinion