NCT06645704已完成1 期
An Open-Label Phase 1 Study in Healthy Male Subjects to Investigate the Absorption, Metabolism and Excretion of [14C]-EP262 Following Single-Dose Oral Administration
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Mass balance of [14C]-EP262
研究概览
简要总结
This study is being conducted to assess the mass balance, pharmacokinetics, and metabolite profiles of a single oral dose of [14C]-EP262 in healthy male participants.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Males aged 18 to 55 years
- •Body mass index of 18 to 32 kg/m2 and body weight of 55 to 100 kg
- •Negative result for HIV, HBV, and HCV at Screening
- •Male subjects with female partners of reproductive potential must be surgically sterile or use adequate birth control
- •No use of tobacco or nicotine containing products within the past 6 months
排除标准
- •History or presence of any condition or prior surgery that could pose a significant risk in the opinion of the investigator
- •History of malignancy within the past 5 years
- •History of any serious allergic reactions or hypersensitivity
- •Recent history of incomplete bladder emptying with voiding or awakening more than once at a night to void
- •Usual habit of bowel movements of less than 1 or more than 3 bowel movements per day
研究组 & 干预措施
[14C]-EP262 25 mg
Experimental
Administered orally.
干预措施: EP262 (Drug)
结局指标
主要结局
Mass balance of [14C]-EP262
时间窗: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Assessed by the total recovery of radioactivity from urine and feces
Pharmacokinetics (PK) of EP262 and [14C]
时间窗: Measured from Day 1 to End of Study or Early Termination (Approximately 1 month)
Assessed by the concentration of EP262 in plasma and \[14C\] in whole blood, plasma, urine, and feces
次要结局
- Metabolite profile of EP262(Measured from Day 1 to End of Study or Early Termination (Approximately 1 month))
- Safety and tolerability of [14C]-EP262(Measured from Day 1 to End of Study or Early Termination (Approximately 1 month))
研究者
研究点 (1)
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