ACTRN12624000547549尚未招募1 期
A Phase 1, Open-label, Dose-escalation Study to Evaluate the Safety and Pharmacokinetics of a Single Intravenous Infusion of TRP-8803 (Psilocin) in Healthy Adult Participants
适应症
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 9
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Non-randomised trial
- 主要目的
- Treatment
- 盲法
- Open (masking not used)
入排标准
- 年龄范围
- 18 Years 至 55 Years（—）
- 性别
- All
入选标准
- •1. Overtly healthy and medically stable in the judgment of the Principal Investigator, as determined by screening medical history, physical examination, ECG, and no clinically significant laboratory abnormality detected on routine blood tests and urinalysis.
- •2. Male and female participants, age 18 to 55 years, inclusive, at the time of signing the ICF.
- •3. Weight between 50kg and 120kg, inclusive; and body mass index (BMI) between 20 and 30, inclusive.
- •4. Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.
- •5. Has adequate venous access for IV administration and for PK blood sampling.
- •6. Contraceptive use by women and men should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies.
- •a. Women of childbearing potential (WOCBP) in sexual relationships with men must use 2 acceptable methods of contraception from 30 days prior to study screening until 30 days after completing the dose of study intervention. Ova donation is not permitted for 30 days after completing the dose of study intervention.
- •b. Men must agree to avoid impregnation of women and sperm donation during and for 90 days after completing the dose of study intervention through use of an acceptable method of contraception.
- •NOTE: acceptable methods of contraception include, but are not limited to, intrauterine device; injected/implanted/intravaginal/transdermal hormonal method; oral hormones plus a barrier contraception; abstinence; vasectomized sole partner; or double barrier contraception (eg, barrier method). The 2 methods of contraception cannot both be hormonal.
- •7. WOCBP must have a negative serum pregnancy test at Screening, and negative urine pregnancy test at Baseline and on psilocin administration day (confirmed before psilocin administration). A WOCBP is any woman (regardless of sexual orientation, having undergone a tubal ligation, or remaining celibate by choice) who meets the following criteria:
- •a. has not undergone a hysterectomy or bilateral oophorectomy, or
- •b. has not been naturally postmenopausal for at least 12 consecutive months (ie, has had menses at any time in the preceding 12 consecutive months)
- •8. Agrees to refrain from using any legal psychoactive substance (except for caffeine, described below), for the following defined time periods:
- •a. Must be non- or ex-smokers (tobacco) and not use other nicotine-containing products from 90 days prior to study drug administration until participant study termination; or use less than 5 tobacco or nicotine-containing products a week by self-report and have a negative cotinine test at Screening and Dose Day (prior to dosing).
- •b. Alcohol for 72 hours prior to the psilocin administration visit by self-report
- •9. Has had no psychedelic drug use in the 3 months prior to psilocin administration visit and agrees to refrain from psychedelic drug use other than study drug during the course of the study by self-report. Psychedelic drugs include but are not limited to psilocybin, LSD, methylenedioxymethamphetamine (MDMA), and ayahuasca. If another suspected psychedelic agent is used, Sponsor must be contacted for approval.
- •10. Agree that for 7 days before the psilocin administration day, including the morning of the dose, participant will refrain from taking any nonprescription medication, nutritional su
排除标准
- •1. Currently meets diagnostic criteria for any Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) psychiatric condition as assessed by the MINI.
- •2. Prior history of primary psychotic disorder (unless substance-induced or due to a medical condition), bipolar disorder Type I or Type II, or schizophrenia, as determined by the MINI.
- •3. Concurrent or recent (within 5 years) history of major depressive disorder, obsessive compulsive disorder, generalized anxiety disorder, panic disorder, anorexia nervosa or bulimia nervosa, overeating disorder, post traumatic stress disorder, or substance use disorder as determined by the MINI and psychiatric history.
- •4. First degree family history of primary psychotic disorder, bipolar disorder Type I or Type II, or schizophrenia, as determined via the Family History Screen form conducted by trained staff.
- •5. Participant has a recent history of suicide attempt (defined as an active, interrupted, or aborted attempt with the past 5 years) or reports suicidal ideation in the past 6 months as indicated by a positive response (Yes”) to either Question 4 or Question 5 of the C-SSRS performed at the Screening Visit.
- •NOTE: If a participant cannot complete the assessment, the site must document this.
- •6. Participant has a history of alcohol abuse disorder within 1 year prior to screening or regular abuse of alcohol within 3months prior to the screening visit (defined as consistently consuming more than 10 units of alcohol per week [1 unit=150mL of wine, 360mL of beer, or 45mL of 40% alcohol]).
- •7. Meets DSM-5 criteria for substance use disorder (other than alcohol) within the past 12 months.
- •8. Vital signs of systolic BP >160mm Hg, diastolic BP >95mm Hg, and HR >100 bpm on 2 or more consecutive readings within 15 minutes.
- •9. Have any of the following cardiovascular conditions: uncontrolled hypertension, coronary artery disease, congenital long QT syndrome, cardiac hypertrophy, cardiac ischemia, congestive heart failure, prior myocardial infarction, tachycardia, artificial heart valve, QTc interval >470msec (women) or >450msec (men), PR >220msec, or QRS >120msec at the Screening visit, any other clinically significant screening ECG abnormality, or any other significant cardiovascular condition at the Principal Investigator’s discretion.
- •10. Currently under treatment for epilepsy.
- •11. Blood chemistry test prior to study intervention administration as follows:
- •a. Any liver function test with results greater than 1.5 times the ULN
- •b. Estimated glomerular filtration rate (by Cockcroft & Gault) less than 60mL/min
- •12. Currently taking (or where applicable, testing positive on urine drug test), drugs of abuse such as amphetamines, buprenorphine, benzodiazepines, cocaine, methamphetamines, MDMA/Ecstasy, morphine, methadone, oxycodone, marijuana, ethyl glucuronide, fentanyl, tramadol, and synthetic cannabinoids (K2). If urine drug test at Screening is positive, a repeat test may be conducted up until Day 1 (the end of the Screening period) at the discretion of the Principal Investigator or delegate.
- •13. Prior adverse effects from psilocybin or other psychedelics based on self-report.
- •14. Currently taking (within 5 half-lives of Visit 5, Dose Day) prohibited medications, including antihypertensive medications, UDP Glucuronosyltransferase Family 1 Member A9 (UGT1A9) or intestinal UDPglucuronosyltransferases 1A10 inhibitors (eg, regorafen
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