NCT05339633已完成1 期
An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C]-D-0502 Following Single Oral Dose Administration
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
- 8
- 试验地点
- 1
- 主要终点
- Radiolabel recovery
研究概览
简要总结
An Open Label Phase 1 Study in Healthy Adult Female Subjects to Determine the Mass Balance Recovery, Absorption, Metabolism, and Excretion of [14C] D-0502 Following Single Oral Dose Administration
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy adult female volunteers not of child-bearing potential between the ages of 18 and
- •Other inclusion criteria will be reviewed by the Principal Investigator.
排除标准
- •History or presence of any condition or prior surgery that, in the opinion of the Investigator, poses a significant risk to subject safety and/or achievement of study objectives
- •Clinically significant abnormal medical history, or any abnormal findings on physical examination, vital signs, ECG, or laboratory tests
- •Other exclusion criteria will be reviewed by the Principal Investigator.
研究组 & 干预措施
Single Dose
Other
All study subjects will receive a a single oral dose of radiolabeled microtracer of D-0502 following an overnight fast
干预措施: [14C]-D-0502 (Drug)
结局指标
主要结局
Radiolabel recovery
时间窗: 14 days
To assess the mass balance (i.e., cumulative excretion in urine and feces) of D 0502 and the percentages of radiolabel recovered in urine and feces following administration of a single oral dose of D-0502/5 microcuries (µCi) \[14C\] D-0502 in healthy, adult female subjects
次要结局
未报告次要终点
研究者
研究点 (1)
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