A study in healthy male volunteers to investigate... — Clinical Trial Details

Open-label, non-randomised single-dose mass-balance study of COMP360 [14C]-psilocybin in healthy males to assess absorption, distribution, metabolism and excretion with urine and faecal collections up to Day 10 and blood PK through Day 8.

Endpoints include plasma and excreta radioactivity recovery, metabolite profiling, PK parameters for psilocin and metabolites, safety assessments (AEs, ECG, vitals, labs), C-SSRS and BPRS+ up to Day 10, and 5D-ASC and psychedelic intensity ratings on Day 1.

Participants

Ages

30 – 55

Sexes

male

BMI

18 - 32

Psychosis History

Excluded

Inclusion Criteria

1. Signed ICF.
2. Healthy Male aged 30 - 55 years at Screening.
3. Body mass index (BMI) of 18 - 32kg/m² at Screening.
4. Minimum weight of 50kg at Screening.
5. Regular bowel movements (average stool production of ≥1 and ≤3 stools per day).
6. Non-smoker (including e-cigarettes) for at least 12 months prior to Screening.
7. Willing to comply with fasting and food intake requirements.
8. Willing to comply with contraception requirements.
9. Participant is judged to have sufficient English language competence that under ordinary circumstances they are able to complete all protocol required assessments without any assistance or alteration to the copyrighted assessments, and agreement to comply with all study visits.

Exclusion Criteria

1. Current or lifetime history of any psychotic disorder or bipolar disorder, as assessed by a structured clinical interview (MINI 7.0.2) or medical records.
2. Borderline personality disorder as demonstrated by medical history or the MINI plus borderline module.
3. Current or clinically relevant history of major depression, panic disorder, PTSD, GAD, OCD, or eating disorder as assessed by the MINI 7.0.2 or documented 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 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.
6. Use of pharmacological compounds for psychiatric or neurological conditions acting on the CNS 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 safe exposure to COMP360 [14C]-psilocybin.
9. Exposure to psilocybin or other classic psychedelics in the past three months, including microdosing; agree not to use psychedelics for study follow-up.
10. Participants who are planning a pregnancy or have pregnant/lactating partners; those who do not agree to use highly effective contraception during participation and for three months after dosing; those planning to donate sperm during study period or within three months after dosing.
11. Active gastrointestinal disease or conditions interfering with drug absorption (eg gastrectomy, bowel resection).
12. Acute diarrhoea or constipation in the 7 days before administration of IMP.
13. Cardiovascular conditions: history of stroke or myocardial infarction, uncontrolled hypertension (>140/90 mmHg), tachycardia (resting HR >100 bpm), prolonged QTcF >450 ms or clinically significant arrhythmia.
14. Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >8%) or recent severe diabetic events.
15. Seizure disorder.
16. Substance use within the last month (excluding alcohol) or positive urine drug screen at Screening/Day -1.
17. Current enrolment in any investigational drug/device study or participation within 90 days or five half-lives prior to Screening.
18. Abnormal clinically significant physical exam, vitals, ECG or labs that pose increased risk.
19. Any other clinically significant major concurrent illness that may interfere with interpretation of results or increase health risk.
20. Hypersensitivity to IMP or excipients.
21. LFTs >1.1×ULN or total bilirubin >ULN at Screening/Day -1 (with repeat policy described in protocol).
22. Positive HBsAg, anti-HCV or anti-HIV I/II at Screening.
23. Clinically significant allergy requiring treatment (hay fever allowed unless active on Day -1/Day 1).
24. Intake of >21 units alcohol weekly, alcohol within 48 hours of Screening or Day 1.
25. Habitual heavy caffeine (>8 cups/day) at Screening or inability to refrain from methylxanthines from 48 hours prior to and during residential visit.
26. Use of prescription or OTC medications including herbal supplements within 15 days or five half-lives prior to dosing, except paracetamol ≤2 g/day up to 48 hours prior and mild laxative if needed post-dose; rescue meds at investigator discretion.
27. Radiation exposure >5 mSv in last 12 months or >10 mSv in last 5 years; occupationally exposed workers excluded.
28. Donation of blood/plasma >400 mL within 3 months prior to and until 4 weeks after dosing.
29. Unsuitable veins for multiple venepuncture/cannulation.
30. Confirmed positive alcohol breath test at Screening or Day -1.
31. Confirmed positive urine cotinine test at Screening or Day -1.
32. Participants who are, or immediate family members of, study site or sponsor employees.
33. Failure to satisfy investigator of fitness to participate for any other reason.

Company

Product

Legal

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

Detailed Description

Study Protocol

Preparation

Dosing

Locations

Integration

Study Arms & Interventions

COMP360 (psilocybin)

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details