Single-center, Open and Single-dose Clinical Trial to Explore the Mass Balance of Oral Suspension of 300 mg /100 μCi [14C] Sulfatinib in Chinese Adult Male Healthy Volunteers
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib
研究概览
简要总结
This is a single-center, open label and single-dose clinical trail, to explore the body mass balance and identify the major metabolites in Chinese adult male healthy volunteers after a single oral dose of [14C]Sulfatinib, to obtain the pharmacokinetic parameters of plasma and observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.
详细描述
In order to determine the optimal time point for sample collection, this study will be divided into two stages: the first stage, two volunteers will be enrolled, the volunteers should stop collecting the corresponding samples by the investigators based on radioactive test results, safety results combined with the actual comprehensive situation. And in the second stage sample collection time for another four volunteers will be determined and adjusted according to the results of the first stage.
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
盲法说明
open label
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of written Informed Consent Form (ICF)
- •Age of 18-50 (inclusive)；
- •Body weight over 50 kg and body mass index (BMI) between 19-26 kg / m2 (inclusive)；
排除标准
- •Laboratory tests (blood tests, blood biochemical tests [fasting], coagulation tests, thyroid function tests, urinalysis, fecal occult blood) judged as clinically significant abnormal by investigators；
- •Clinically significant abnormal ECG at screening and before screening；
- •Hepatitis B surface antigen (HBsAg), e antigen (HBeAg) or hepatitis C antibody (HCV Ab) test positive；
- •Human immunodeficiency virus (HIV) antibody positive；
- •Treponema pallidum antibody positive.
研究组 & 干预措施
[14C]Sulfatinib
This is a single center and single dose in 6 volunteers. Subject would take a suspension containing 300 mg of Sulfatinib (containing about 100 μCi of radioactivity) within 1 hour after standard breakfast.
干预措施: [14C]Sulfatinib (Drug)
结局指标
主要结局
To investigate the area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration (AUCt) of total radioactivity of [14C] Sulfatinib
时间窗: Measured from the 0 hour to 216 hours
The area under the plasma concentration-time curve (AUC) from 0 to the time of the last measurable concentration.
次要结局
- To investigate the time to Cmax (peak time, Tmax) of total radioactivity of [14C] Sulfatinib(Measured from the 0 hour to 216 hours)
- To investigate Half-life (t1/2) of total radioactivity of [14C] Sulfatinib(Measured from the 0 hour to 216 hours)
- To observe the safety of healthy volunteers after a single oral dose of [14C]Sulfatinib.(Measured from the date signed ICF to within 15 days after the single dose)
- To investigate the Maximum observed plasma concentration (Cmax) of total radioactivity of [14C] Sulfatinib(Measured from the 0 hour to 216 hours)
- To obtain mass balance data after a single oral dose of [14C] Sulfatinib(Measured on the Day1 to Day15)