NCT06303648已完成1 期
A Single, Ascending Dose Evaluation of the Safety, Pharmacokinetics of Methylone in Healthy Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- AUC: Area under the plasma concentration-time curve for methylone
研究概览
简要总结
This is an open-label, single, ascending dose study evaluating the PK and safety of methylone in healthy subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult male or female aged 25 to 55 inclusive
- •Normal resting ECG
- •Normal hematologic and hepatic function
- •Normal renal function
排除标准
- •Vital sign abnormalities
- •Positive urine drug screen at screening and / or Day -1
- •Current mental illness such as depression, anxiety disorder, schizophrenia or other psychotic disorders
研究组 & 干预措施
Cohort 4
Experimental
200 mg x 1 dose
干预措施: Methylone (Drug)
Cohort 5
Experimental
150 mg + 100 mg x 1
干预措施: Methylone (Drug)
Cohort 5
Experimental
150 mg + 100 mg x 1
干预措施: Placebo (Drug)
Cohort 1
Experimental
50 mg x 1 dose
干预措施: Methylone (Drug)
Cohort 2
Experimental
100 mg x 1 dose
干预措施: Methylone (Drug)
Cohort 3
Experimental
150 mg x 1 dose
干预措施: Methylone (Drug)
结局指标
主要结局
AUC: Area under the plasma concentration-time curve for methylone
时间窗: 48 hours following the dose
Cmax: Maximum Observed Plasma Concentration for methylone
时间窗: 48 hours following the dose
次要结局
- Incidence and frequency of adverse events(10 days after the dose)
研究者
研究点 (1)
Loading locations...
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