Single Dose ADME Study of [14C]-CORT125329 in Healthy Male Subjects (QSC206122)
Research type
Research Study
Full title
An Open Label, Single-dose, Single-period Study Designed to Assess the Mass Balance Recovery, Metabolite Profile and Metabolite Identification of [14C]-CORT125329 in Healthy Male Subjects
IRAS ID
1006127
Contact name
Hazel Hunt
Contact email
Sponsor organisation
Corcept Therapeutics Incorporated
Eudract number
2022-002574-90
ISRCTN Number
ISRCTN20653849
Research summary
Research Summary
The Sponsor is developing the test medicine, CORT125329, for the potential treatment of antipsychotic-induced weight gain (AIWG). AIWG is the condition in which patients taking antipsychotic medications have a tendency to gain weight. In addition, antipsychotic medications can increase the risk of patients developing cardiovascular disease (diseases of the heart/blood vessels).
This study will aim to look at how the test medicine is taken up, broken down and removed by the body when given orally as capsules after food. To help investigate this, the test medicine will be radiolabelled. ‘Radiolabelled’ means that the test medicine has a radioactive component, in this case Carbon-14 which is a type of naturally occurring radioactivity. The safety and tolerability of this test medicine will also be studied.
This study will take place at one non-NHS site, and will consist of a single study period involving up to 6 healthy male volunteers, aged between 45 and 70.
Subjects will be admitted to the clinic the evening before the day of dosing. On Day 1, following consumption of a standard breakfast, subjects will receive a single 1200 mg dose of the radiolabelled test medicine as 12 x 100 mg capsules.
Subject’s blood, urine and faeces will be taken throughout the study for analysis of the test medicine and its breakdown products, and for their safety. A cerebrospinal fluid sample will be taken on one occasion.
Subjects will remain in the clinic up to Day 11, however if the relevant radioactivity elimination criteria have been met for all subjects before Day 11, they may be discharged early as a group. If the relevant criteria have not been met by Day 11, subjects may remain in the clinic (up to Day 13). Home collections of urine and/or faeces may be required.
Subjects are expected to be involved in this study for approximately 6 weeks from screening to follow-up phone call.
Summary of results
This study was sponsored by Corcept Therapeutics Incorporated and conducted by Quotient Sciences (a clinical research organisation) at its clinical unit in Nottingham, UK.
The study took place from 23 Nov 2022 until 12 Jan 2023.
We would like to take this opportunity to thank all study volunteers.
What was this study about?
The aim of this study was to find out how the body takes up, breaks down and removes the test medicine, CORT125329, when it is given by mouth to healthy men. This was done by ‘labelling’ the test medicine with a radioactive component (carbon-14; also referred to as 14C). 14C is a type of naturally occurring radioactivity that allows tracking of the test medicine to see how it is removed from the body.
The study also looked at how well tolerated the test medicine was and whether it reaches the fluid surrounding the brain and spinal cord (cerebrospinal fluid, also referred to as CSF).
Who took part in this study?
6 healthy men took part in the study. The volunteers were aged 53 to 70 years old.
How was this study done?
The study was open-label. This means that the volunteers knew the treatment they were receiving.
Volunteers arrived at the clinic the day before dosing. On Day 1, each volunteer swallowed the radiolabelled test medicine, as 12 × 100 mg capsules (a total of 1200 mg) with water, after breakfast. Volunteers went home on Day 12 or Day 13.
Blood samples, urine and faeces (poo) were collected from the volunteers and analysed to find out how the body breaks down and removes the test medicine. A sample of CSF was also taken via a lumbar puncture (a procedure done by inserting a thin needle between the bones in the lower spine).
The study staff also collected information about the volunteers’ health throughout the study.
What were the results of this study?
The test medicine reached the bloodstream about half an hour after it had been swallowed. The highest blood levels of test medicine occurred between 2 to 3 hours after the test medicine was swallowed.
The test medicine was also detected in the CSF.
After the volunteers had taken the radiolabelled test medicine, most of the radioactivity was found in the faeces (poo). The rest was found in the urine. These results mean that the liver does most of the processing and removal of the test medicine from the body.
There was more radioactivity in the blood than the test medicine, which is likely to mean that the body processes the test medicine into metabolite(s) (i.e. byproduct(s) of the test medicine). Further tests will be done on the blood samples to find out more about these metabolites.
The test medicine was well tolerated in the healthy volunteers.
Did the participants have any unwanted effects?
Yes
Unwanted effects occurred in 2 of the 6 volunteers who took the test medicine. However, these unwanted effects were mild, were not thought to be caused by the test medicine and most unwanted effects had cleared up by the follow-up phone call, 5 to 8 days after the volunteers went home.
Where can I find more information about this study?
For more information about the study, go to www.isrctn.com and search for the ISRCTN number: ISRCTN20653849REC name
HSC REC B
REC reference
22/NI/0155
Date of REC Opinion
26 Oct 2022
REC opinion
Favourable Opinion