The Mass Balance Study of [14C]JT001 in Chinese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 7
- 试验地点
- 1
- 主要终点
- cumulative excretion rate of total radioactive material in fecal matter
研究概览
简要总结
This study is a single center, single dose, non-randomized, open design clinical study.By quantitative analysis of the biological samples of subjects after oral administration of [14C]JT001, the data of human radioactive excretion rate and the main excretion pathway will be obtained. The main metabolites ,metabolic pathways and elimination pathways of JT001 will be identified.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy adult males
- •Age: 18-45 years old
- •Body weight: Body mass index (BMI) is between 19.0 and 26.0 kg/m2 (including boundary values), and the body weight of the subject is not less than 50.0 kg;
- •Voluntarily sign informed consent;
- •Subjects were able to complete the trail according to protocol.
排除标准
- •Physical examination, vital signs, routine laboratory examination, imaging examination abnormal and clinically significant
- •The electrocardiogram was abnormal and was considered clinically significant by the investigators, or has a history of organic heart disease
- •Has hepatitis B (HBV) or hepatitis C (HCV) or HIV antibody and syphilis antibody positive;
- •Any drug that inhibits or induces the drug transporters P-gp and BCRP has been used within 30 days prior to the screening period
- •Any conditions that may affect drug absorption.
- •Previous antineoplastic therapy meets washout requirements.
- •Hemorrhoids or perianal disease with regular/ongoing blood in the stool, irritable bowel syndrome, inflammatory bowel disease
- •Habitual constipation or diarrhea.
- •Significant radioactive exposure within 1 year.
研究组 & 干预措施
[14C]JT001
干预措施: [14C]JT001 (Drug)
结局指标
主要结局
cumulative excretion rate of total radioactive material in fecal matter
时间窗: 1 month
After oral administration of the drug, the subjects collected feces for 10 Days to obtain the excretion of accumulated radioactive substances in feces
time to peak（Tmax）
时间窗: 1 month
After a single dose, the time of peak blood concentration
Total radioactive recovery
时间窗: 1 month
The percentage of radioactivity recovered from collected samples
Peak concentration（Cmax）
时间窗: 1 month
The highest plasma drug concentration that can be achieved after medication
elimination half life（t1/2）
时间窗: 1 month
the time it takes the blood to reduce the concentration of the drug to half
Major metabolites in human plasma, urine, and feces by liquid chromatography-mass spectrometry (LC-MS/MS)
时间窗: 1 month
The main metabolites in plasma, urine and fecal samples will be identified by liquid chromatography-mass spectrometry (LC-MS/MS)
次要结局
- Adverse events (AEs)(2 month)