NCT02293967已完成1 期
An Open-label, Mass Balance Study to Investigate the Absorption, Metabolism and Excretion of [14C] MT-1303 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
- 8
- 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-1303 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
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 30 Years 至 65 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Caucasian male aged 30 to 65 at Screening.
- •Body weight of ≥60 kg, and a BMI ranging from 18.0 to 32.0 kg/m2 at Screening and Day -
- •Normal or not clinically significant ECG as defined by a HR between 50 and 100 bpm inclusive at Screening, Day -1 and pre-dose.
- •Vital signs within the following ranges at Screening and Day -1,Body temperature: 35.0 to 37.5 °C,SBP: 90 to 140 mmHg,DBP: 50 to 90 mmHg.
- •Regular daily bowel movements.
排除标准
- •Radiation exposure, including that from the present study, excluding background radiation but including diagnostic x-rays and other medical exposures, exceeding 5 mSv in the last 12 months or 10 mSv in the last 5 years. No occupationally exposed worker, as defined in the Ionising Radiation Regulations 1999, shall participate in the study.
- •Previous medical history of tuberculosis, or in the opinion of the Investigator, a recurrent medical history of cold sores, pharyngitis, urinary tract infection, diarrhoea/dysentery, chest infections or fungal infections.
- •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 or 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;
- •history of major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection
研究组 & 干预措施
MT-1303
Experimental
[14C] MT-1303 after a single oral dose
干预措施: MT-1303 (Drug)
结局指标
主要结局
Total radioactivity in urine and faeces
时间窗: up to 10 weeks
次要结局
- PK of total radioactivity in plasma(up to 10 weeks)
研究者
研究点 (1)
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