A Phase 1 Study Comparing the Pharmacokinetics and Safety of Intravenous and Oral Psilocybin
试验速览
- 阶段
- 1 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin
研究概览
简要总结
The purpose of this research study is to compare an oral dose of psilocybin and an intravenous (IV) infusion of psilocybin to assess differences in how the drug is absorbed by the body, the psychedelic experience, and any side effects when taken by healthy adult participants. Participants can expect to be in the study for approximately 12 weeks.
详细描述
Psilocybin, when delivered to screened and prepared participants in a controlled environment, has shown strong evidence of positive effects in treating cancer-related psychiatric distress, depression and anxiety, treatment-resistant depression, and nicotine or alcohol addiction. Psilocybin therapy is generally safe and well-tolerated when conducted under controlled conditions. Psilocybin is very rapidly transformed to the active metabolite psilocin, which is considered the active agent from psilocybin administration. Oral and IV psilocybin are expected to have similar pharmacokinetic and psychedelic effects, as well as safety profiles, while IV psilocybin will achieve more consistent blood levels than are possible with oral psilocybin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Overall healthy and medically stable, as determined by screening
- •Capable of giving signed informed consent
- •Negative urine pregnancy test in persons of childbearing potential
排除标准
- •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, corrected QT interval (QTc) >450 msec at screening, any other clinically significant screening ECG abnormality, or any other significant cardiovascular condition
- •Presence of a gastrointestinal disease that could interfere with absorption of an orally administered drug
- •Have epilepsy
- •Positive urine drug test
- •Prior adverse effects from psilocybin or other psychedelics that required hospitalization
- •Currently taking on a regular basis (e.g., daily) any medications having a primary centrally acting serotonergic effect, including selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), or serotonin-acting dietary supplements (such as 5-hydroxy-tryptophan or St. John's wort)
- •Currently taking prohibited medications, including antihypertensive medications, UGT1A9 or 1A10 inhibitors (e.g., regorafenib, rifampicin, phenytoin, eltrombopag, mefenamic acid, diflunisal, niflumic acid, sorafenib, isavuconazole, deferasiroxor, ginseng), and aldehyde or alcohol dehydrogenase inhibitors (e.g,, disulfiram)
- •Participation in another concurrent clinical study; or use of investigational drugs, biologics, or devices within 30 days prior to assignment of study drug administration order
- •Anyone who is pregnant, lactating, or planning on becoming pregnant during the study
- •Unwilling to withhold prohibited concomitant medications
研究组 & 干预措施
Oral and IV psilocybin
Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water, at one visit. Psilocybin will be administered through IV at the other visit.
干预措施: IV Psilocybin (Drug)
Oral and IV psilocybin
Psilocybin with psychological support: Psilocybin will be administered in the form of capsules, taken orally with water, at one visit. Psilocybin will be administered through IV at the other visit.
干预措施: Oral Psilocybin (Drug)
结局指标
主要结局
Determine the maximum concentration of psilocin following oral and IV administrations of psilocybin
时间窗: Day 8, Day 22
Determine the maximum plasma concentration of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
Determine the concentration of psilocin following oral and IV administrations of psilocybin
时间窗: Day 8, Day 22
Determine the AUC of psilocin in plasma following a single IV dose as compared to that following a single oral dose.
Difference in the area under plasma concentration-time curve (AUC) between psilocybin administration methods.
时间窗: Day 8, Day 22
AUC will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
Difference in the maximum concentration (Cmax) between psilocybin administration methods.
时间窗: Day 8, Day 22
Cmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
Difference in the time to maximum plasma concentration (Tmax) between psilocybin administration methods.
时间窗: Day 8, Day 22
Tmax will be determined after oral and IV psilocybin doses to assess for more consistent blood concentration.
次要结局
- Characterize the incidence and severity of adverse events associated with doses of psilocybin in healthy adults(12 weeks)
- Suicidal ideation(12 weeks)