NCT01150812终止1 期
A Phase I, Single-center, Single-blind, Randomized, Placebo-controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of Oral AZD8165 After Single Oral Ascending Doses in Healthy Male Subjects
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 终止
- 发起方
- AstraZeneca
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of AZD8165 and the pharmacokinetics of the metabolite AZ12971554 and plasma levels of the prodrug AZD8165 after escalating single oral low doses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Suitable veins for cannulation or repeated venipuncture
- •Have a body mass index (BMI) between 19 and 30 kg/m2 and weigh at least 50 kg and nor more than 100 kg
排除标准
- •History of any clinically significancy disease or disorder which, in the opinion of the Investigator, may either put the volunteer at risk because of participation in the study, or influence the results or the volunteer's ability to participate in the study
- •History or presence of gastrointestinal, hepatic or renal disease or any other condition known to interfere with absorption, distribution, metabolism or excretion of drugs
- •Personal or family history of bleeding disorders, or reasonable suspicion of vascular malformations, including aneurysms.
研究组 & 干预措施
1
Experimental
干预措施: AZD8165 (Drug)
结局指标
主要结局
Safety variables (adverse events, Electrocardiograms, vital signs, safety labs)
时间窗: Approximately 64 days including a screening period, 3 treatment periods, 2 washout periods, and a follow-up period.
次要结局
- Plasma and urine levels of AZD8165 and its active metabolite AZ12971554(Serial blood and urine samples will be taken over 24 hours after oral administration to evaluate AZD8165 and its active metabolite AZ12971554)
- Coagulation times (namely Activated Partial Thromboplastin Time,Ecarin Clotting Time, Thrombin Clotting Time(Serial blood samples will be taken over 24 hours after oral administration to evaluate Activated Partial Thromboplastin Time (APTT), Ecarin clotting Time (ECT), Thrombin Clotting Time (TCT))
研究者
研究点 (1)
Loading locations...
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