An Open-label, Randomised, Uncontrolled Trial Investigating the Pharmacokinetics of CRD007 After Single Dose Administration to Subjects With Abdominal Aortic Aneurysm (AAA)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Pharmacokinetics - maximum plasma concentration (Cmax)
研究概览
简要总结
The purpose of the study is to determine the plasma levels of CRD007 in patients with abdominal aortic aneurysms after the administration of single doses of tablets containing 10, 25 and 40 mg CRD007.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Infra-renal abdominal aortic aneurysm
排除标准
- •Significant concurrent disease or medical conditions that are deemed to interfere with the pharmacokinetics or the safety of CRD007 conduct of the trial
研究组 & 干预措施
CRD007 10 mg
CRD007, 10 mg tablet, single dose
干预措施: CRD007 (Drug)
CRD007 25 mg
CRD007, 25 mg tablet, single dose
干预措施: CRD007 (Drug)
CRD007 40 mg
CRD007, 40 mg tablet, single dose
干预措施: CRD007 (Drug)
结局指标
主要结局
Pharmacokinetics - maximum plasma concentration (Cmax)
时间窗: Pre-dose and until 12 hours post-dose
Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as Cmax will be measured
Pharmacokinetics - time to maximum plasma concentration (tmax)
时间窗: Pre-dose til 12 hours post-dose
Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as tmax will be measured.
Pharmacokinetics - Area under the plasma concentration curve (AUC)
时间窗: Pre-dose until 12 hours post-dose
Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as AUC will be measured.
Pharmacokinetics - elimination half life (t1/2)
时间窗: pre-dose until 12 hours post-dose
Plasma concentrations of CRD007 will be measured and standard pharmacokinetic parameters as t1/2 will be measured
次要结局
- Dose linearity(Pre-dose and until 12 hours post-dose)
- Potential for accumulation(Pre-dose untill 12 hours post-dose)