ISRCTN16636661进行中（未招募）1 期
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
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 14
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
- All
入选标准
- •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
排除标准
- •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 International Neuropsychiatric Interview, Version 7.0.2 [MINI Version 7.0.2] and Mini International Neuropsychiatric Interview, Version 7.0.2 – Plus borderline personality module [MINI-Plus])
- •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, as determined by Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (MINI 7.0.2) within 12 months prior to Screening
- •4. Use of pharmacological compounds for psychiatric or neurological conditions acting on the central nervous system within 30 days (or five half-lives, whichever is longer) 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, such as ayahuasca, mescaline, LSD, or peyote within 12 months prior to Screening. Additionally, participants must agree not to use psychedelics other than COMP360 for the duration of the study.
- •8. Pregnancy, lactating or planning a pregnancy
- •9. Engagement in sexual intercourse which could result in pregnancy, must agree to use a highly effective contraceptive method throughout their participation in the study and for 3 months after their final COMP360 administration. Participants of childbearing potential must have a negative serum pregnancy test at Screening, and a negative urine pregnancy test the day prior to COMP360 administration (Day -1 of each treatment period).
- •10. Participants should be informed not to donate eggs for the duration of the study period and for 30 days after their final COMP360 administration, or to donate sperm for the duration of the study period, and for at least three months after their final COMP360 administration
- •11. Cardiovascular conditions:
- •11.1. Lifetime history of stroke
- •11.2. Lifetime myocardial infarction
- •11.3. Clinically significant arrhythmia (<1 year prior to signing the ICF) or tachycardia (resting heart rate over 100 beats per minute)
- •11.4. Blood pressure >140/90 mmHg at screening or prior to COMP360 administration on Day 1, following triplicate readings
- •11.5. Elongated QT interval corrected by Fridericia (QTcF; interval >450 msec for men and >470 msec for women) at screening or prior to COMP360 administration on Day 1, following triplicate readings.
- •12. Type 1 diabetes mellitus or uncontrolled type 2 diabetes mellitus (defined by haemoglobin A1c [HbA1c] >8% at Screening) or a history of diab
研究者
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