Metabolism and Disposition of [14C] Herombopag in Chinese Healthy Human Subjects
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
- total radioactivity in the excreta
研究概览
简要总结
This study is a single-center, open-label, single-dose design. It is planning to enroll six Chinese healthy adult male subjects. The metabolism and disposition of Herombopag, will be studied in these subjects after a single oral administration of a solution dose of [14C] Herombopag (5 mg, 100 uCi).
详细描述
The metabolism and disposition of Herombopag, will be studied in six healthy men after a single oral administration of a solution dose of [14C]eltrombopag (5 mg,100 uCi).
The sutdy will investigate total radioactivity pharmacokinetics in whole blood and plasma 、quantitatively analyze the the total radioactivity in the excreta、evaluate the predominant route of elimination and indentify the Metabolite profiles in plasma 、urine and faces.
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
- •Health male subjects, age between 18-45 years.
- •BMI between 19 and 26 kg/m2 .
- •Signed informed consent.
排除标准
- •Abnormal results in physical examination、laboratory tests、X-ray、abdominal ultrasound、echocardiography have clinical significance.
- •Abnormal platelet counts or platelet aggregation has clinical significance.
- •Abnormal troponin examination has clinical significance.
- •Abnormal ophthalmic examination has clinical significance.
- •Hepatitis B surface antigen, hepatitis C antibody, syphilis antibody or HIV antibody is positive.
- •Those who have a history of allergies to test drugs or similar drugs.
- •Those who have undergone surgery within 6 months prior to the trial .
- •Those who took any drug within 14 days before the test (including Chinese herbal medicine).
- •Any drug that inhibits or induces liver drug metabolism within 30 days before the test.
- •Subjects who have participated in other clinical trial within the 3 months prior to study entry.
- •One or more non-pharmacological contraceptive measures cannot be used during the trial or it is planned to have birth within one year.
研究组 & 干预措施
Hetrombopag Olamine
Hetrombopag Olamine (5 mg, 100 uCi)
干预措施: Hetrombopag Olamine (Drug)
结局指标
主要结局
total radioactivity in the excreta
时间窗: From 24 hour before administration to 336 hours after administration
Excretion of radioactivity in human urine and feces
individual metabolite profiles in plasma 、urine and faces
时间窗: From 24 hour before administration to 336 hours after administration
Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse individual percentage of metabolites.
Total radioactivity pharmacokinetics in whole blood and plasma
时间窗: From 1 hour before administration to 240 hours after administration
plasma concentration of total radioactivity
the concentration of Hetrombopag in plasma
时间窗: From 1 hour before administration to 240 hours after administration
Area under the plasma concentration versus time curve (AUC)
mean metabolite profiles in plasma 、urine and faces
时间窗: From 24 hour before administration to 336 hours after administration
Using quantitative High Performance Liquid Chromatography-Mass Spectroscopic method to analyse mean percentage of metabolites.
次要结局
未报告次要终点