Phase I ADME Study of COMP360[14C]-psilocybin (QSC301617)
Research type
Research Study
Full title
A Phase I, Open-Label, Single-Dose, Mass Balance Study to Investigate the Absorption, Distribution, Metabolism, and Excretion of COMP360 [14C]-Psilocybin in Healthy Male Participants
IRAS ID
1010247
Contact name
Matthew Anderton
Contact email
Sponsor organisation
Compass Pathfinder Limited
ISRCTN Number
ISRCTN37167117
Research summary
The Sponsor is developing the test medicine, COMP360, for the potential treatment of treatment-resistant depression. Depression is a common mental health problem that can cause people to experience low mood, loss of motivation or pleasure, feelings of guilt or low self-worth, disturbed sleep, changes in appetite, low energy and concentration. Patients with treatment-resistant depression see no improvement in their symptoms with standard depression medication.
In this study, we’ll give healthy 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’ - it will contain a small amount of radioactivity (Carbon-14) - so that we can track it in the body.
In this study in healthy volunteers, we aim to answer these questions.
• Does the test medicine cause any important side effects?
• How much test medicine enters the bloodstream and how quickly does the body get rid of it?This study will take place at one non-NHS site in Nottingham.
We plan to enrol 6 healthy men aged 30-55 years.
Volunteers will receive a single dose of radiolabelled test medicine, as a capsule by mouth. They’ll stay in the clinic for up to 10 nights and take up to 5 weeks to finish the study.
We’ll collect blood and urine samples to do safety tests. Over a period of at least 8 days, we’ll take many blood samples and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.
REC name
North East - York Research Ethics Committee
REC reference
24/NE/0118
Date of REC Opinion
17 Sep 2024
REC opinion
Further Information Favourable Opinion