[14C]CS0159 in Chinese Healthy Subjects for Mass Balance Phase I Study
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- Mass Balance
研究概览
简要总结
Study of [14C]CS0159 in China Healthy Subjects.
详细描述
A phase I study to quantify the total mass balance in healthy subjects after a single dose of [14C]CS0159.
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 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Healthy male subjects between the ages of 18 and 45 years (inclusive).
- •Subjects should not weigh less than 50 kg, BMI between 19~26 kg/㎡.
- •No sperm donation or fertility plan during the study and within 12 months after the end of the study.
- •Understand the purpose and requirements of trial, subjects who have voluntarily participated in the study and signed the ICF, completion of tests as required.
排除标准
- •With abnormal and clinically significant comprehensive physical examinations, vital signs,laboratory examinations, 12-ECG, chest X-ray, and abdominal ultrasound.
- •12-ECG QT(QTcF)>450ms.
- •The history of drug allergy.
- •Patients with malabsorption and gastrointestinal disorders or history of Vomiting, diarrhoea in the week prior to the screening period.
- •Patients with difficulty swallowing or interfere with drug absorption.
- •HBs Ag or E antigen, TPAb, or HIV-Ag/Ab positive person.
- •Have taken any clinical trial medication or participated in any other clinical trial within 3 months prior to the screening period.
- •Habitual constipation or diarrhoea.
- •Heavy smokers addicts
- •Heavy drinker addicts.
- •Has drug abuse history or positive drug abuse test results.
- •Heavy caffeine addicts.
- •Special dietary requirements.
- •Poor adherence or any other conditions judged by the investigator as not suitable for the study.
研究组 & 干预措施
[14C]CS0159
Single oral dose of 4mg [14C]CS0159
干预措施: [14C]CS0159 (Drug)
结局指标
主要结局
Mass Balance
时间窗: Screening period (-48 hours) to 240 hours
Mass balance recovery of total radioactivity in urine and fecal samples.
[14C] CS0159 metabolite
时间窗: Screening period (-48 hours) to 240 hours
Identification of the major metabolites of CS0159 in human plasma, urine and faeces, determine the main Determine the main biotransformation pathways and calculate the percentage of the administered dose of the prodrug and each metabolite in urine and faeces, and plasma prodrugs and circulating metabolites as a percentage of total exposure AUC.
Radioactivity of CS0159
时间窗: Up to 90 hours post dose
Whole blood to plasma total radioactivity ratio
Area under the curve
时间窗: Up to 90 hours post dose
Total radioactivity in plasma PK: AUC
Highest radioactivity observed plasma concentration
时间窗: Up to 90 hours post dose
Total radioactivity in plasma PK: Cmax
Time for Cmax
时间窗: Up to 90 hours post dose
Total radioactivity in plasma PK: Tmax
Elimination half-life
时间窗: Up to 90 hours post dose
Total radioactivity in plasma PK: T1/2
次要结局
- Tmax of CS0159(Up to 90 hours post dose)
- Adverse events(Up to 240 hours post dose)
- Blood plasma PK(Up to 90 hours post dose)
- AUC of CS0159(Up to 90 hours post dose)
- T1/2 of CS0159(Up to 90 hours post dose)
- Cmax of CS0159(Up to 90 hours post dose)