Single-center, Open-label, Multi-dose Study to Investigate the Human Mass Balance in Healthy Adult Male Following Multiple Oral Doses of HMPL-523 Tablets Followed by a Single Oral Dose of 300 mg/150 µCi [14C]HMPL-523 Suspension
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Hutchmed
- 入组人数
- 6
- 试验地点
- 1
- 主要终点
- the Human Mass Balance
研究概览
简要总结
To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects following multiple oral doses of HMPL-523 tablets followed by a single oral dose of [14C]HMPL-523 suspension
详细描述
a single-center, non-randomized, open-label, human mass balance, phase 1 study to evaluate the absorption, metabolism and excretion following multiple oral doses of HMPL-523 tablets, followed by a single oral dose of 300 mg/150 µCi [14C]HMPL-523 suspension in healthy adult male Chinese subjects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Sequential
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Subjects who have voluntarily participated in the study and signed the informed consent form with good compliance;
- •Healthy male subjects aged 18-40 years (inclusive);
- •Subjects weighing ≥ 50 kg
- •Subjects in good health status
排除标准
- •Subjects with a history of gastrointestinal surgery, renal surgery, cholecystectomy and other procedures that in the judgment of the investigator may affect drug absorption or excretion
- •hypersensitivity to the investigational product and its excipients
- •Subjects with diseases affecting the absorption, distribution, metabolism and excretion of oral drugs,
- •Subjects with fear of needles, hemophobia, difficulty collecting venous blood, or special requirements for diet, who cannot comply with uniform diet
- •Subjects who are abnormal with clinical significance for C-reactive protein or positive for coronavirus nucleic acid detection in coronavirus infection screening
- •Subjects who have participated in another clinical trial of other drugs and have received such investigational product within 3 months prior to the first dose
- •Having any other diseases or conditions that may affect the normal performance of the study or the evaluation of the study data, or having other conditions that are not suitable for the study, as judged by investigators
研究组 & 干预措施
HMPL-523
HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of [14C]HMPL-523 suspension
干预措施: HMPL-523 (Drug)
HMPL-523
HMPL-523 Tablet 300 mg QD7 days followed by a single oral dose of [14C]HMPL-523 suspension
干预措施: 150 µCi [14C]HMPL-523 (Drug)
结局指标
主要结局
the Human Mass Balance
时间窗: Day8
To evaluate the absorption, metabolism and excretion of HMPL-523 in healthy male Chinese subjects followed by a single oral dose of \[14C\]HMPL-523 suspension
次要结局
未报告次要终点