NCT03158506已完成1 期
An Open-Label, Single Center Study to Assess the Absorption, Metabolism, Excretion, and Mass Balance of a Single Oral Dose of 50 mg (90 uCi) [14C]-HMS5552 in Healthy Adult Male Subjects
Hua Medicine Limited1 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2017年3月29日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Total radioactivity in blood, plasma urine and feces
研究概览
简要总结
This is an open-label, single center, 1-period study in healthy adult male subjects to assess absorption, metabolism, and excretion of HMS5552 after a single oral administration of 50 mg (90 μCi) of [14C]-HMS5552.
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
- 19 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy, adult, male 19-55 years of age
- •Weight at least 50 kg, and BMI within the range of 18-30 kg/m2
- •Written informed consent must be obtained before any assessment is performed
排除标准
- •History or presence of clinically significant medical, surgical or psychiatric condition or disease in the opinion of the Investigator or designee which might significantly alter the absorption, distribution, metabolism and excretion of drugs.
- •History or presence of alcoholism or drug abuse.
- •Abnormal bowel habits.
研究组 & 干预措施
[C14]-labelled HMS5552
Experimental
干预措施: HMS5552 (Drug)
结局指标
主要结局
Total radioactivity in blood, plasma urine and feces
时间窗: Up to 168 hours
Total radioactivity in urine and faeces at each time interval and cumulative radioactivity (mass balance)
次要结局
- Concentrations of HMS5552 and its metabolites in plasma, urine and feces(Up to 168 hours)
- Number of participants with adverse events as a measure of safety and tolerability(Up to 168 hours)
研究者
研究点 (1)
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