Clinical TrialHealthy VolunteersPsilocybinPsilocybinCompleted

A phase I, open-label, randomised-sequence, two-way crossover study to assess the relative oral bioavailability of 25 mg and 5 mg strength capsules of COMP360 in healthy volunteers

Phase I open-label randomised two-way crossover PK study in healthy volunteers (n=14) comparing 25 mg COMP360 as a single 25 mg capsule versus five 5 mg capsules in the fed state.

Target Enrollment
14 participants
Study Type
Phase I interventional
Design
Randomized

Detailed Description

Randomised-sequence, two-period crossover in healthy volunteers to assess relative oral bioavailability of COMP360 25 mg delivered as 1×25 mg versus 5×5 mg capsules; each participant receives both regimens in separate dosing periods.

Primary endpoints are plasma PK parameters for psilocin (Cmax, AUC0-24h, AUC0-inf); secondary endpoints include additional PK metrics, safety assessments (AEs, vitals, ECG, labs), and psychiatric measures including C-SSRS and BPRS+.

Study Protocol

Preparation

sessions

Dosing

2 sessions

Integration

sessions

Study Arms & Interventions

25 mg (1x25)

experimental

Single 25 mg COMP360 capsule (test); one dosing period of crossover.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    1 x 25 mg capsule; fed state.

25 mg (5x5)

active comparator

Five 5 mg COMP360 capsules (reference); one dosing period of crossover.

Interventions

  • Psilocybin25 mg
    via Oral• single dose• 1 doses total

    5 x 5 mg capsules; fed state.

Participants

Ages
18 – 55
Sexes
Male & Female

Inclusion Criteria

  • 1. Signed ICF
  • 2. Male or female aged between 18 and 55 years old at screening
  • 3. Body mass index between 18.5 and 30.0 at screening
  • 4. Weight ≥50 kg at screening
  • 5. Non-smoker (including e-cigarettes) for at least 12 months prior to screening
  • 6. Willing to comply with fasting and food intake requirements
  • 7. Able to complete all protocol required assessments and agree to comply with all study visits

Exclusion Criteria

  • Current exclusion criteria as of 16/08/2022:
  • 1. Current or clinically relevant history of any psychotic disorder, bipolar disorder, borderline personality disorder, major depression, panic disorder, post-traumatic stress disorder, generalised anxiety disorder, obsessive-compulsive disorder, or eating disorder, as assessed by a structured clinical interview (MINI Version 7.0.2 and MINI-Plus borderline personality module)
  • 2. A history of suicide attempts, suicidal ideation or suicidal behaviour as determined by the C-SSRS at Screening or at Day 1; or clinical assessment of significant suicidal risk or risk of self-injury identified during participant interview
  • 3. Satisfying diagnostic criteria for alcohol or substance use disorder (DSM-5) within 12 months prior to Screening
  • 4. Use of pharmacological compounds for psychiatric or neurological conditions acting on the CNS within 30 days (or five half-lives) prior to Screening
  • 5. In first-degree relatives, a history of psychotic disorders or mood disorders, including bipolar disorders and depressive disorders
  • 6. Other personal circumstances or behaviour judged by the investigator to be incompatible with the establishment of rapport or the safe exposure to COMP360
  • 7. Exposure to psilocybin or any other psychedelics within 12 months prior to Screening; participants must agree not to use psychedelics other than COMP360 during the study
  • 8. Pregnancy, lactating or planning a pregnancy; participants of childbearing potential must use highly effective contraception and have negative pregnancy tests as specified
  • 9. Donation of eggs/sperm restrictions as specified
  • 10. Cardiovascular conditions (lifetime stroke, myocardial infarction, clinically significant arrhythmia <1 year, tachycardia >100 bpm, BP >140/90 at screening, prolonged QTcF >450 ms men/>470 ms women)
  • 11. Type 1 diabetes or uncontrolled type 2 diabetes (HbA1c >8%)
  • 12. Seizure disorder
  • 13. Recent substance use within last month (excluding alcohol) or positive urine drugs screen
  • 14. Current enrolment in another investigational study or within specified washout periods
  • 15. Abnormal clinically significant physical/lab/ECG findings at screening or Day -1
  • 16. Any other clinically significant concurrent illness that may interfere with study results or participant safety
  • 17. Elevated liver enzymes >1.5 x ULN at screening or Day -1
  • 18. Positive hepatitis B/C or HIV tests at screening
  • 19. Excessive alcohol or heavy caffeine use as specified
  • 20. Use of prescription or non-prescription medications within specified washout (exceptions apply)
  • 21. COVID-19 vaccination within seven days of first COMP360 administration
  • 22. Recent blood/plasma donation as specified
  • 23. Hypersensitivity to investigational product or excipients
  • 24. Clinically significant allergy requiring treatment (hay fever allowed unless active)
  • 25. Unsuitable veins for venepuncture
  • 26. Evidence of current SARS-CoV-2 infection or residual symptoms
  • 27. Confirmed positive alcohol breath or urine cotinine tests at screening or Day -1
  • 28. Immediate family members of site or sponsor employees
  • 29. Failure to satisfy investigator of fitness to participate

Study Details

Locations

Quotient Sciences Limited — Nottingham, United Kingdom

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