A study carried out on healthy volunteers to... — Clinical Trial Details

This interventional Phase I trial enrolled 44 healthy volunteers to characterise the pharmacokinetics and safety of oral COMP360 (psilocybin), using single‑dose PK cohorts (1, 10, 25, 50 mg; 6 active:2 placebo per cohort) and a separate food‑effect crossover (25 mg fasted vs fed).

Primary endpoints include adverse events, 12‑lead ECG/QTcF monitoring, vital signs and clinical laboratories; secondary endpoints include plasma concentrations of psilocybin, psilocin and metabolites and PK parameters.

Dosing was observed in a clinical research unit with overnight stay for 24‑hour monitoring; suicidality assessments (C‑SSRS) and post‑dose safety checks were performed prior to discharge.

Participants

Ages

18 – 55

Sexes

Male & Female

BMI

18.5 - 30

Psychosis History

Excluded

Inclusion Criteria

1. Signed ICF.
2. Participant is male or female from any ethnic origin.
3. Participant is aged between 18 to 55 years, inclusive, at Screening visit 1 (V1).
4. Participant has a body mass index of 18.5 to 30 kg/m2, inclusive, at Screening (V1) and day 1 (V3).
5. Participant is a non-smoker (including e-cigarettes) for at least 12 months prior to Screening (V1) and day 1 (V3).
6. Negative RT-PCR test for SARS-CoV-2 at Screening (V1) and day -1 (V2).
7. Willing to comply with fasting and food intake requirements.
8. Healthy as determined by a responsible physician, based on medical evaluation including medical history, physical examinations, prior and concomitant medications, vital signs, 12-lead ECG and clinical laboratory evaluations.
9. Male participants must use a condom during the study and for 3 months after their final dose of study medication if their partner is a woman of childbearing potential. In addition, their female partner of childbearing potential must use an additional method of highly protective contraception from first dosing until 3 months following the final dosing.
10. Female participants: 10.1. Of childbearing potential must be established on a highly effective method of contraception prior to dosing until 3 months after the last dose in combination with male partner’s use of a condom during the trial and for 3 months after the last dose of trial medication. Participants must have a negative pregnancy test at Screening (V1) and day 1 (V3). 10.2. Of non-childbearing potential i.e., postmenopausal or permanently sterile following hysterectomy, bilateral salpingectomy and bilateral oophorectomy. Postmenopausal is defined as women ≥60 years and having had >12 months of natural (spontaneous) amenorrhea, and a serum follicle-stimulating hormone level in the menopausal range, unless the subject is taking hormone replacement therapy or is using hormonal contraception.
11. In the FE component, the participant is willing to eat a high-fat breakfast, including bacon, in line with Food and Drug Administration guidance.
12. Able to complete all protocol-required assessment tools without any assistance or alteration to the copyrighted assessments, and to comply with all study visits.

Exclusion Criteria

Psychiatric Exclusion Criteria:
1. Current (within the last year) or history of alcohol or substance abuse (including nicotine) as informed by DSM-5 at Screening (V1), as determined by self-report or a positive urine drugs of abuse test, alcohol breath test and urine cotinine screen at Screening (V1) or day 1 (V3).
2. Use of pharmacological compounds for psychiatric or neurological conditions acting on the central nervous system within 30 days or 5 half-lives (whichever is longer) prior to Screening (V1).
3. Current or clinically relevant history of schizophrenia, psychotic, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, major depression, panic disorder, generalised anxiety disorder, obsessive-compulsive disorder, eating disorder or body-dysmorphic disorder, as assessed by MINI.
4. In first-degree relatives, a history of schizophrenia, psychotic, bipolar disorder, delusional disorder, paranoid personality disorder, schizoaffective disorder, borderline personality disorder, major depression, panic disorder, generalised anxiety disorder, obsessive-compulsive disorder, eating disorder or body-dysmorphic disorder.
5. Significant suicide risk as defined by: 5.1. Suicidal ideation as endorsed on items 4 or 5 on the C-SSRS within 1 year prior to Screening (V1), or on day 1 (V3), or 5.2. Suicidal behaviours within 1 year prior to Screening (V1), or 5.3. Clinical assessment of significant suicidal risk during Participant interview.
6. Other personal circumstances and behaviour that is incompatible with establishment of rapport or safe exposure to psilocybin, as judged by the Investigator.
7. Exposure to psilocybin, or any other psychedelics, such as ayahuasca, mescaline, LSD, or peyote within 1 year prior to Screening (V1).
General Medical Exclusion Criteria:
8. Women of childbearing potential who are pregnant, breastfeeding, or planning to conceive.
9. Clinically relevant history of abnormal physical or mental health interfering with the study.
10. Clinically relevant abnormal laboratory results ...
11. Current or previous medical history of any cardiovascular conditions. Participants with a blood pressure ≥140/90 mmHg at Screening (V1) or day 1 (V3), following triplicate readings, will not be eligible.
12. Recent substance use within the last month (excluding alcohol) or a positive urine drugs screen.

Company

Product

Legal

A study carried out on healthy volunteers to understand how COMP360 can be taken in a safe and well-tolerated way

Detailed Description

Study Protocol

Preparation

Locations

Dosing

Integration

Study Arms & Interventions

COMP360

Interventions

Placebo

Interventions

Participants

Inclusion Criteria

Exclusion Criteria

Study Details