A Phase 1, Open-label, Single Period Study to Evaluate the Absorption, Metabolism, and Excretion of a Single Microdose of [14C]-RE104 in Healthy Participants
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 1
- 主要终点
- Total excreted radioactivity (Ae)
研究概览
简要总结
The purpose of this study is to characterize the absorption, metabolism and routes of excretion of RE104 and its metabolites in healthy volunteers. This study will quantify drug and metabolites in blood, urine, and feces samples collected before study drug administration and through at least 168 hours after SC dosing of [14C]-RE104.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Between 18 and 55 years of age (inclusive), and a body mass index of 18-34 kg/m
- •Willing to take a drug with psychoactive properties
- •If female and of childbearing potential, agrees to use an acceptable method of birth control and is not planning to become pregnant before, during or within 90 days after the last dose of the study drug.
- •If male, must agree to use condom with spermicide during and up to 90 days after discharge."
- •Must agree to refrain from sperm or egg donation until 120 days post discharge.
- •Able to understand and adhere to study schedule and requirements and willing to sign an ICF
- •In good general health as determined by medical history, clinical laboratory test results, vital sign measurements, 12-lead ECG results, and physical examination findings at screening
- •Agrees to not participate in other research studies involving investigational medication or medical devices for the duration of the study
排除标准
- •Active or medical history of bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder, or first-degree family history of psychosis or bipolar disorder.
- •Medical condition or other concomitant condition or history rendering unsuitability for the study
- •Has used or intends to use prohibited medications
- •Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
- •Has participated in another clinical study within 30 days and/or with a [14C] labeled study drug within 1 year prior to enrolling.
- •Is pregnant or has a female partner who is pregnant
研究组 & 干预措施
30 mg 2-[14C]-RE104 (1uCi/30mg)
A single subcutaneous injection of 30 mg 2-[14C]-RE104 for Injection
干预措施: 2-[14C]-RE104 for Injection (Drug)
结局指标
主要结局
Total excreted radioactivity (Ae)
时间窗: Through 168 hours postdose
Cumulative recovery of total excreted radioactivity (CUM Ae)
时间窗: Through 168 hours postdose
Area under the concentration-time curve (AUC) for RE104 and 4-OH-DiPT
时间窗: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT
时间窗: Through 168 hours postdose
Time to reach Cmax (Tmax) for RE104 and 4-OH-DiPT
时间窗: Through 168 hours postdose
Terminal half-life (t1/2) of RE104 and 4-OH-DiPT
时间窗: Through 168 hours postdose
Apparent terminal elimination half-life (λz) for RE104 and 4-OH-DiPT
时间窗: Through 168 hours postdose
Mean residence time (MRT)
时间窗: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104
时间窗: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104
时间窗: Through 168 hours postdose
Total metabolite profiling with description of relevant PK parameters and structural identification of major metabolites present in all matrices
时间窗: Through 168 hours postdose
次要结局
- Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness(From dosing (Day 0) through study completion (Day 7))