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Contact Information:

Ms Zainab Alashe
-
clinicaloperations@compasspathways.com


Dr Study Contact
+44 (0)330 3031000
recruitment@weneedyou.co.uk


Study Location:

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Be Part of Research - Trial Details - A study in healthy male volunteers to investigate how the test medicine COMP360 [14C]-psilocybin is taken up, broken down and removed from the body
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A study in healthy male volunteers to investigate how the test medicine COMP360 [14C]-psilocybin is taken up, broken down and removed from the body

Not Recruiting

Open to: Male

Age: Adult

Nottingham

Medical Conditions

Treatment-resistant depression (TRD). Study to be conducted in healthy volunteers

This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.


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, healthy volunteers will be given 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. This study on healthy volunteers aims to answer whether the test medicine causes any important side effects, how much test medicine enters the bloodstream and how quickly the body gets rid of it.

Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.  

The recruitment start and end dates are as follows:

12 Dec 2024 23 Jan 2025

This study will take place at one non-NHS site in Nottingham. Volunteers will receive a single dose of radiolabelled test medicine, in a capsule by mouth. They will stay in the clinic for up to 10 nights and take up to 5 weeks to finish the study. During the study blood and urine samples will be collected to do safety tests. Over at least 8 days, many blood samples will be taken and volunteers will collect all their urine and faeces so that we can measure the amount of test medicine and its breakdown products.


Healthy male volunteers aged 30-55 years old

You can take part if:



You may not be able to take part if:


1. Current or lifetime history of any psychotic disorder or bipolar disorder, as assessed by a structured clinical interview (Mini International Neuropsychiatric Interview, Version 7.0.2 [MINI 7.0.2] or documented via available medical records. 2. Borderline personality disorder as demonstrated by medical history or the Mini International Neuropsychiatric Interview Plus (MINI plus) – borderline personality disorder module.3. Current or clinically relevant history of major depression, panic disorder, post-traumatic stress disorder, generalised anxiety disorder, obsessive-compulsive disorder, or eating disorder as assessed by the MINI 7.0.2 or documented via available medical records. 4. A history of suicide attempts, suicidal ideation or suicidal behaviour as determined by the Columbia-Suicide Severity Rating Scale (C-SSRS) at Screening, Day -1 or at Day 1; or clinical assessment of suicidal risk or risk of self-injury identified during other participant assessments. 5. Alcohol or substance use disorder within the 12 months prior to Screening as assessed by the MINI 7.0.2 or documented via available medical records.6. Use of pharmacological compounds for psychiatric or neurological conditions acting on the central nervous system within the last 30 days or five half-lives (whichever is longer) prior to Screening.7. In first-degree relatives, a history of psychotic disorders or bipolar disorder.8. Other personal circumstances or behaviour judged by the investigator to be incompatible with the establishment of rapport or safe exposure to COMP360 [14C]-psilocybin.9. Exposure to psilocybin, or any other classic psychedelics, such as ayahuasca, mescaline, lysergic acid diethylamide (LSD), dimethyltryptamine (DMT), 5-Methoxy-N,N-dimethyltryptamine (5-MeO-DMT), or peyote during the past three months prior to Screening, including microdosing. Additionally, the participant must agree not to use psychedelics for the duration of the study follow-up so as not to confound results. 10. Participants who are planning a pregnancy.11. Participants with pregnant or lactating partners. 12. Participants who engage in sexual intercourse which could result in pregnancy, and who do not agree to use a highly effective contraceptive method throughout their participation in the study and for three months following COMP360 [14C]-psilocybin administration.13. Participants who plan to donate sperm within the study period or within three months following COMP360 [14C]-psilocybin administration.14. Presence of active gastrointestinal disease or other condition (eg gastrectomy, bariatric surgery, small bowel or large bowel resection) that may interfere significantly with the absorption of drugs. 15. Acute diarrhoea or constipation in the 7 days before administration of investigational medicinal product (IMP) in the study. If screening occurs >7 days before the day of administration, this criterion will be determined on the morning prior to administration.16. Cardiovascular conditions: lifetime history of stroke, lifetime myocardial infarction, uncontrolled hypertension (resting blood pressure >140/90 mmHg), tachycardia (resting heart rate over 100 beats per minute), elongated QT interval corrected by Fridericia (QTcF; interval >450 ms) or clinically significant arrhythmia.17. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined by haemoglobin A1c [HbA1c] >8% at Screening) or a history of diabetic ketoacidosis, hyperglycaemic coma, or severe hypoglycaemia with loss of consciousness (<3 months prior to the signing of ICF).18. Seizure disorder.19. Substance use within the last month (excluding alcohol) including but not limited to cannabis, cocaine, ketamine, opiates, and 3,4 MDMA or a confirmed positive urine drug screen for illicit drugs or drugs of abuse at Screening and/or Day -1.20. Current enrolment in any investigational drug or device study, or participation in such within 90 days or five half-lives (whichever is longer) of Screening. 21. Abnormal and clinically significant results on the physical examination, vital signs, electrocardiogram (ECG), or laboratory tests at Screening or Day -1 that in the investigator’s opinion may constitute a risk for an individual who is exposed to COMP360 [14C]-psilocybin. 22. Any other clinically significant cardiovascular, pulmonary, gastrointestinal, hepatic, renal, endocrine, metabolic, or any other major concurrent illness that, in the opinion of the investigator, may interfere with the interpretation of the study results or constitute a health risk for the participant if they take part in the study.23. Hypersensitivity to the investigational product or any of the excipients.24. Participants with aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase >1.1 x the upper limit of normal (ULN) or total bilirubin levels >ULN at Screening or Day -1. Additionally, participants with creatinine clearance as determined by the Cockcroft-Gault method of <80ml/min at Screening. These laboratory evaluations may be repeated once at the discretion of the investigator. If the repeat test is <1.1 × ULN for aspartate aminotransferase, alanine aminotransferase, gamma-glutamyl transferase or 21 units of alcohol weekly, consumption of alcohol within 48 hours of Screening, or from within 48 hours of Day 1. One unit is equivalent to half a pint of beer or one 25 mL measure of 40% spirits, 1.5 to 2 units is equivalent to one 125 mL glass of wine.28. Habitual and heavy consumption of caffeinated beverages (>8 cups of coffee or equivalent per day) at Screening; and/or unable to refrain from the use of (methyl) xanthine (eg coffee, tea, cola, chocolate) from 48 hours prior to and for the duration of the residential study visit.29. Use of any prescription or non-prescription medications, including herbal and nutritional supplements, or over-the-counter (OTC) medications (eg ibuprofen, aspirin) within 15 days or five half-lives (whichever is longer) of COMP360 [14C]-psilocybin administration and throughout the study. By exception, the participant may take paracetamol (≤2 g/day for up to 48 hours prior to dosing) and a mild laxative if an individual participant has not experienced a bowel movement in any 36-hour period post-dose. Rescue medication or other medications deemed necessary by the investigator are permitted at the investigator’s discretion.30. Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 2017, shall participate in the study.31. Donation of blood or plasma of >400 mL within three months prior to and until four weeks after COMP360 [14C]-psilocybin administration.32. Participants who do not have suitable veins for multiple venepuncture/cannulation as assessed by the investigator or a delegate at Screening.33. A confirmed positive alcohol breath test at Screening or Day -1.34. A confirmed positive urine cotinine test at Screening or Day -1.35. Participants who are, or are immediate family members of, a study site or sponsor employees.36. Failure to satisfy the investigator of fitness to participate for any other reason.


Below are the locations for where you can take part in the trial. Please note that not all sites may be open.

  • Quotient Sciences Limited
    Mere Way, Ruddington Fields
    Nottingham
    NG11 6JS

Participants will get no medical benefit from taking part in this study. it is hoped that the development of a product to improve the treatment of treatment-resistant depression will be of benefit to patients with this condition.
Volunteers may experience side effects from the test medicine. The test medicine is early in development so there is little information about its effects in humans. Full information on possible side effects is in the Participant Information Sheet and Informed Consent Form. There is always a risk of unexpected side effects or an allergic reaction. To mitigate the risk, we’ll ensure that volunteers meet the entry criteria for the study and monitor volunteers closely throughout the study.
As the test medicine is CNS acting with psychedelic effects and may have an effect on healthy volunteer’s mental health, the medicine will be administered alongside therapist psychological support. Questionnaires and scales will be used to regularly monitor these effects during the study and rescue medications will be available, if required. The questionnaire and scales will be performed by an appropriately trained physician.
Volunteers will be exposed to 3.8 milliSieverts (mSv) of radioactivity during the study, which is equivalent to about 17 months’ exposure to average background radiation in the UK (2.7 mSv). This equates to the radiation dose that would result from 2.5 CT scans of the head (1.6 mSv each). That amount of radiation poses negligible risk to the volunteers’ health but volunteers should not take part in this study if they have had radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years.
Our screening tests might be of benefit if we find an important medical problem, but they might reveal something that the volunteer would prefer not to know about. If there are medically important findings in our tests at screening, or during the study, we will inform the volunteer’s GP.
The test medicine might harm unborn children, so all volunteers must follow the restrictions on the donation of sperm and use acceptable contraception. Were a partner of a volunteer to become pregnant during the study, we would ask permission to follow up on the pregnancy.
• Blood sampling can cause soreness and bruising of the arms but these problems usually clear up within a few days to a few weeks. Susceptible volunteers may faint when we take blood samples; volunteers must lie down when we take blood samples to mitigate that risk.
• ECG stickers may cause local skin irritation.
Volunteers will receive payment for participating in the study. There is always a risk that payment could represent coercion. However, payment will be based on committed time, inconvenience, and travel and other expenses, not on risk. An ethics committee will review the payment to ensure that it is fair.

Dr Study Contact
+44 (0)330 3031000
recruitment@weneedyou.co.uk


Ms Zainab Alashe
-
clinicaloperations@compasspathways.com



The study is sponsored by Compass Pathfinder Limited and funded by Compass Pathfinder Limited.



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Read full details for Trial ID: ISRCTN37167117
Last updated 27 January 2025

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