NCT06877247已完成1 期
A Mass Balance Study of [14C] SHR6508 in Chinese Hemodialysis Subjects With Secondary Hyperparathyroidism
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Cumulative excretion of radioactivity
研究概览
简要总结
The study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of [14C] SHR6508.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Be able and willing to provide a written informed consent form.
- •Male subjects and postmenopausal women.
- •Meet the Body Mass Index (BMI) standard.
排除标准
- •Subjects with a history of cardiovascular diseases.
- •Subjects with gastrointestinal diseases.
- •Subjects with a history of surgery.
- •Subjects with a history of blood loss.
- •Abnormal blood pressure.
- •Be allergic to a drug ingredient or component.
- •Subject with a history of alcohol abuse and drug abuse
- •The investigators determined that other conditions were inappropriate for participation in this clinical trial.
研究组 & 干预措施
[14C] SHR6508 Injection Group
Experimental
干预措施: [14C] SHR6508 Injection (Drug)
结局指标
主要结局
Cumulative excretion of radioactivity
时间窗: Day 1 to Day 168.
Percentage of parent drug and its metabolites in plasma as a percentage of total radioactive exposure (%AUC)
时间窗: Day 1 to Day 6.
次要结局
- Adverse Events (AEs)(About 24 weeks.)
- Serious adverse Events (SAEs)(About 24 weeks.)
研究者
研究点 (1)
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