The Mass Balance and Biotransformation Study of [14C] Donafenib in Chinese Healthy Adult Male Volunteers
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
- Quantitive analysis of whole radioactivity of excrement of orally administered [14]Donafenib in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body
研究概览
简要总结
This study was designed to evaluate the mass balance and biotransformation after single-dose of [14C]Donafenib orally in Chinese healthy adult male volunteers, revealing the overall pharmacokinetic characteristics of Donafenib in humans, and providing a reference for the rational administration.
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
Nonrandomized and open labeled study
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
- •A healthy male adult.
- •Age is between 18 and 45, inclusive.
- •Body mass index is between 19 and 26, inclusive.
- •Voluntarily to provide informed consent form.
- •Willing and able to communicate with investigators and complete the trial according to clinical trial protocol.
排除标准
- •Any abnormal and clinical significant findings.
- •A positive examination result of HBsAg/HBeAg, HIV antibody and treponema pallidum antibody.
- •Volunteers who had participated in a radiolabeled clinical study or were exposed to significant levels of radiation for any reasons within the 12 months prior to the study.
- •Volunteers who had used of prescription or herbal products that may affect the drug metabolism within 30 days before the study.
- •Volunteers who had blood loss/donation up to 400 mL within 3 months before the screening, or received blood transfusion within 1 month.
研究组 & 干预措施
[14C]Donafenib
干预措施: [14C]Donafenib (Drug)
结局指标
主要结局
Quantitive analysis of whole radioactivity of excrement of orally administered [14]Donafenib in Chinese healthy adult male volunteers to obtain the mass balance data and the main excretion pathway in human body
时间窗: from 0 hour to 240 hours after administration
The percentage of radioactive dose of \[14C\] radiolabelled Donafenib recovered in urine, faeces and in total
Identification of the main metabolite and biotransformation pathway of Donafenib and investigation of metabolite in plasma by LC-RAM/HRMS
时间窗: from 0 hour to 240 hours after administration
Proportion of different metabolites
Quantitive analysis of the concentrations of Donafenib in plasma using the validated LC-MS/MS to obtain pharmacokinetic data
时间窗: from 0 hour to 240 hours after administration
The concentrations of Donafenib in plasma
次要结局
- Adverse Events(Up to 7 days (approx) from the start of administration)