A study carried out on healthy volunteers to understand how COMP360 can be taken in a safe and well-tolerated way
- Conditions
- Treatment-resistant depressionMental and Behavioural Disorders
- Registration Number
- ISRCTN17905443
- Lead Sponsor
- COMPASS Pathfinder, Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 44
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.
Psychiatric Exclusion Criteria:
1. Current (within the last year) or history of alcohol or substance abuse (including nicotine) as informed by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (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 a structured clinical interview (Mini International Neuropsychiatric Interview [MINI], Version 7.0.2).
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 (defined as any subject requiring medical, psychological or pharmacotherapeutic intervention for mental illness) interfering with the study as determined by medical history and physical examinations obtained during Screening (V1) as judged by the Investigator (including [but not limited to], thyroid, metabolic, pulmonary, neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal hepatic or renal disorder, or any other major concurrent illness).
10. Clinically relevant abnormal laboratory results (including hepatic and renal panels, complete blood count, chemistry panel and urinalysis), 12-lead ECG, vital signs, or physical findings at Screening (V1) and/or day -1 (V2) as judged by the Investigator, that in the Investigator’s opinion may constitute a risk for an individual who is exposed to psilocybin. In case of uncertain or questionable results, tests performed during Screening (V1) may be repeated once to confirm eligibility or judged to be clinically irrelevant for healthy participants.
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 to take part in this study.
12. Recent substance use within the
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary safety and tolerability endpoints (single dose PK and FE components) include:<br>1. Adverse events recorded at Day-1, pre-dose day 1, post-dose day 1, post-dose day 2, and day 7<br>2. 12-lead electrocardiogram (ECG) measured using cardiac Holter monitoring data extraction at day-35 to day-2 up to post-dose day 2<br>3. Vital signs measured at pre-dose day 1 to post-dose day 2<br>4. Clinical laboratory tests including clinical chemistry, haematology and urinalysis measured at Day-1 to post-dose day 2<br>5. Suicide risk assessed using the Columbia-Suicide Severity Rating Scale (C-SSRS) at Day-1, pre-dose day 1, dosing/post-dose day 1, post-dose day 2, up to follow-up visit day 7
- Secondary Outcome Measures
Name Time Method