A Two-Cohort, Open-Label, Single and Multiple Dose Pharmacokinetic Study of 90 mg and 180 mg Doses of AZD6140 in Healthy Chinese Volunteers Living in China
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- AZD6140 and AR-C124910XX concentration
研究概览
简要总结
This will be a single centre study conducted at the 3rd hospital affiliated to Peking University. Approximately 24 healthy Chinese volunteers, male and female, will be recruited to obtain at least 20 evaluable volunteers. The primary objective of this study is to characterize the pharmacokinetics of AZD6140 and its active metabolite AR-C124910XX after single and multiple (twice daily) doses of AZD6140 90 mg and 180 mg in healthy Chinese volunteers. The secondary objective of this study is to determine the safety and tolerability of single and multiple (twice daily) 90 mg and 180 mg doses of AZD6140 by physical examination, clinical laboratory tests, vital signs, and collection of adverse events in healthy Chinese volunteers.
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
- All
- 接受健康志愿者
- 是
入选标准
- •Chinese ethnicity defined as having both parents and 4 grandparents who are Chinese
- •Have a normal Body size and weigh at least 50 kg
排除标准
- •History of diseases or other condition known to interfere with the absorption, distribution, metabolism or excretion of drugs determined by the investigator
- •Current and/or past history of intolerance or hypersensitivity to drugs with a similar chemical structure or mechanism of action to AZD6140 or any ingredient in its formulation
- •Symptoms of any clinically significant illness within 2 weeks of screening
- •A personal or family history of bleeding diatheses or a reasonable suspicion of vascular abnormalities including aneurysms
结局指标
主要结局
AZD6140 and AR-C124910XX concentration
时间窗: -2,0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours on days 4,5,6,7,8and 9. Day 10 the samples are at the specified timeframes (0,0.5,1,2,3,4,6,8,12,18,24,36,48,72 hours)
次要结局
- determine the safety and tolerability of single and multiple doses of AZD6140 by physical examination, clinical laboratory tests, vital signs, and collection of adverse events(day -1, 4, 7, 10, 13+3~5)