ISRCTN37167117进行中（未招募）1 期
A phase I, open-label, single-dose, mass balance study to investigate the absorption, distribution, metabolism, and excretion of COMP360 [14C]-psilocybin in healthy male participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 6
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
入选标准
- •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.
排除标准
- •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.
- •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.
- •Participants who are planning a pregnancy.
- •Participants with pregnant or lactating partners.
- •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.
- •Participants who plan to donate sperm within the study period or within three months following COMP360 [14C]-psilocybin administration.
- •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, o
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