A Phase 1, Open-label, Single Dose Study to Evaluate the Concentration of RE104 and Its Major Metabolites in Breast Milk and Plasma of Healthy Lactating Women.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk
研究概览
简要总结
The purpose of this study is to obtain data necessary to characterize the elimination of RE104 and metabolites from breastmilk of health lactating volunteers to support a regulatory assessment of when mothers can safely return to breastfeeding following a single-dose of RE104 for Injection.
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 45 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Females between 18 and 45 years of age, at least 50 kgs, and a body mass index of 18-34 kg/m2
- •Has been breastfeeding or actively pumping for at least 4 weeks postpartum
- •Agrees to cease breastfeeding for duration of study (Day 14) and confirms infant is able to feed from a bottle at screening.
- •Willing and able to pump in order to maintain sufficient milk supply volumes for the study
- •Is not pregnant or planning to become pregnant during the study
- •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
排除标准
- •Has mastitis or other condition that would prevent the collection of milk from one or both breasts
- •Active or medical history of significant mental disorder (including but not necessarily limited to major depression and anxiety disorders, bipolar disorder, schizophrenia, schizoaffective disorder, psychotic disorder and/or borderline personality disorder), or first-degree family history of psychosis or bipolar disorder
- •Medically significant condition or other concomitant condition or history rendering unsuitability for the study, in the judgement of the investigator
- •Has used or intends to use of prohibited medications
- •Has a known sensitivity or intolerance to hallucinogenic or psychedelic substances, or potential rescue medications
研究组 & 干预措施
30 mg RE104
A single subcutaneous injection of 30 mg RE104 for Injection
干预措施: RE104 for Injection (Drug)
结局指标
主要结局
Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for RE104 and 4-OH-DiPT in plasma and breast milk
时间窗: Through 24 hours postdose
Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for RE104 and 4-OH-DiPT in plasma and breast milk
时间窗: Through 168 hours postdose
Maximum observed concentration (Cmax) for RE104 and 4-OH-DiPT in plasma and breast milk
时间窗: Through 168 hours postdose
Time to reach Cmax (tmax) for RE104 and 4-OH-DiPT in plasma and breast milk
时间窗: Through 168 hours postdose
Apparent total body clearance (CL/F) for RE104 in plasma
时间窗: Through 168 hours postdose
Apparent volume of distribution during the terminal phase (Vz/F) for RE104 in plasma
时间窗: Through 168 hours postdose
Apparent terminal elimination half-life (t1/2) for RE104 and 4-OH-DiPT in plasma
时间窗: Through 168 hours postdose
Milk to plasma (M/P) ratio for RE104 and 4-OH-DiPT in breast milk
时间窗: Through 168 hours postdose
Relative infant dose (RID) of RE104 and its active entity 4-OH-DiPT
时间窗: Through 72 hours postdose
Total RID of RE104 and its active entity 4-OH-DiPT
时间窗: Through 168 hours postdose
次要结局
- Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUClast) for detectable/quantifiable RE104 metabolites in plasma and breast milk(Through 168 hours postdose)
- Maximum observed concentration (Cmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk(Through 168 hours postdose)
- Time to reach Cmax (tmax) for detectable/quantifiable RE104 metabolites in plasma and breast milk(Through 168 hours postdose)
- Apparent terminal elimination half-life (t1/2) for detectable/quantifiable RE104 metabolites in plasma(Through 168 hours postdose)
- Milk to plasma (M/P) ratio for detectable/quantifiable RE104 metabolites in breast milk(Through 168 hours postdose)
- Amount of RE104 and its active entity 4 OH-DiPT excreted into breast milk (Ae) and amount of drug excreted into breast milk relative to dose (Fe)(Through 168 hours postdose)
- Unbound and bound plasma concentrations of the RE104 active entity 4-OH-DiPT.(1, 3 and 8 hours post-dose)
- Incidence of treatment-emergent adverse events (TEAEs) by frequency, severity and seriousness.(From dosing through study completion (post-dose follow-up is for 14 days))
- Area under the concentration-time curve from time zero to 24 hours post-dose (AUC0 24) for detectable/quantifiable RE104 metabolites in plasma and breast milk(Through 24 hours postdose)