NCT02900235已完成1 期
An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C]-MT-3995 After a Single Oral Dose to Healthy Male 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
- 9
- 试验地点
- 1
- 主要终点
- Total radioactivity in urine and faeces
研究概览
简要总结
The purpose of this study is to investigate the absorption, metabolism and excretion of MT-3995 in healthy subjects.
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
- 35 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Able to provide written informed consent to participate in the study
- •Caucasian male aged at least 35 years at Screening
- •Healthy and free from clinically significant illness or disease at Screening and Day-1
- •A body weight of 60 to 110 kg at Screening and Day-1
- •Vital signs within the following ranges at Screening, Day-1 and Pre-dose:
- •Body temperature : 35.0°C to 37.5°C
- •Systolic blood pressure: 90 to 140 mmHg
- •Diastolic blood pressure: 50 to 90 mmHg
- •Regular daily bowel movements
排除标准
- •Presence or history of severe adverse reaction or allergy to any medicinal product
- •Participation in more than three clinical studies of an Investigational Medicinal Product (IMP) in the previous year or participated in a clinical study of any IMP within 12 weeks or five half-lives
- •Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs or which may jeopardise the subject in case of participation in the study. The Investigator should be guided by evidence of any of the following:
- •History of inflammatory bowel syndrome, gastritis, ulcers, gastrointestinal or rectal bleeding considered clinically significant by the Investigator
- •History of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy or bowel resection
- •History or clinical evidence of pancreatic injury or pancreatitis
研究组 & 干预措施
MT-3995
Experimental
[14C]-MT-3995 after a single oral dose
干预措施: MT-3995 (Drug)
结局指标
主要结局
Total radioactivity in urine and faeces
时间窗: up to 99 days
Maximum observed plasma concentration [Cmax]
时间窗: up to 99 days
Time at which Cmax occurs [tmax]
时间窗: up to 99 days
Area under the plasma concentration-time curve from time zero to the last measurable concentration [AUC0-t]
时间窗: up to 99 days
Area under the plasma concentration-time curve from time zero to infinity [AUC0-∞]
时间窗: up to 99 days
Apparent terminal elimination half-life [t1/2]
时间窗: up to 99 days
Terminal elimination rate constant [Kel]
时间窗: up to 99 days
次要结局
- Safety and tolerability as measured by adverse events (AEs)(up to 99 days)
- Safety and tolerability as measured by vital signs(up to 99 days)
研究者
研究点 (1)
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