Mass Balance Study of [14C] D-2570 in Chinese Healthy Adult Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 入组人数
- 8
- 主要终点
- Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
研究概览
简要总结
Radiolabeled drug substance balance clinical studies are commonly used methods to elucidate the metabolic and excretion characteristics of drugs in the human body. They are widely applied in the research and development of innovative drugs both domestically and internationally, and their safety has been validated through extensive human trials. The primary objectives of this study are as follows:
To quantitatively analyze the total radioactive activity (TRA) in urine and feces, thereby determining the radioactive recovery rate in humans and identifying the primary excretion pathways. To obtain radioactive metabolite profiles in human plasma, urine, and feces, identify the major metabolites, and determine the principal metabolic and elimination pathways. To quantitatively analyze the total radioactive activity in whole blood and plasma, derive the pharmacokinetic parameters for total radioactivity in plasma and whole blood (if applicable), and investigate the distribution of total radioactivity between whole blood and plasma.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 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
- •The subject must voluntarily participates in this study after full informed consent.
- •Chinese male healthy subjects aged 18-45 years (inclusive) at the time of signing the ICF
- •At screening, subject's body weight is ≥50.0 kg, with a body mass index (BMI) between 19.0 kg/m² and 26.0 kg/m² (inclusive)
- •Subjects have no plans for reproduction or sperm donation during the trial and for 6 months after study drug administration. Subjects agree to practice complete abstinence, have undergone sterilization surgery, or agree to use effective contraception from the time of ICF signing throughout the entire study period until 6 months after study drug administration.
排除标准
- •Findings from screening assessments judged by the investigator as abnormal and clinically significant
- •History of infection as defined in the protocol.
- •Any of the medical diseases or disorders listed in the protocol.
- •Unable to comply with the lifestyle restrictions stipulated in the protocol.
- •Medication history does not meet the requirements of the protocol.
研究组 & 干预措施
[14C] D-2570 group
干预措施: [14C] D-2570 group (Drug)
结局指标
主要结局
Percentage of unchanged drug and its metabolites in plasma, urine and feces to the administered dose
时间窗: 2 weeks
Total recovery in excrement (the ratio of the radioactivity in excrement samples to the radioactivity of the administered drug)
时间窗: 2 weeks
Total Radioactivity of D-2570 in Plasma and Whole Blood
时间窗: baseline to 2 weeks
Whole blood/plasma ratio for TRA (total radioactivity) at different time points
时间窗: Baseline to 2 weeks
次要结局
- Incidence and severity of AEs based on NCI CTCAE V6.0(Baseline to 3 weeks)
- Blood concentration of D-2570(Baseline to 2 weeks)
- Blood concentration of D-2570 metabolites (if applicable)(Baseline to 2 weeks)