NCT01154621已完成1 期
A Phase I, Double-blind, Randomized, Placebo-Controlled Study to Assess the Safety and Tolerability, and Pharmacokinetics of a Single Dose of AZD9742 in Healthy Elderly Male and Female Volunteers
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.
研究概览
简要总结
The aim of this study is to examine the safety and tolerability of a single dose of AZD9742 in elderly individuals.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female volunteers at age of 65 years or older with suitable veins for cannulation or repeated venipuncture, in good health (based on medical history and physical examination and clinical laboratory tests) as judged by the investigator.
- •Female volunteers must be postmenopausal (cessation of regular menses for 12 months and a follicle stimulating hormone level of more than 40IU/L abd estradiol of less than 20ng/mL.
- •Male volunteers should be willing to use barrier contraception, ie, condoms, from the day of dosing until 3 months after dosing with the investigational product.
排除标准
- •History of any clinically significant 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
- •History or presence of GI, hepatic, or renal disease or any other condition known to interfere with absorption, distribution, metabolism, or excretion of drugs as judged by Investigator.
- •Any clinically significant illness, medical/surgical procedure, or trauma within 4 weeks of the first administration of investigational product
研究组 & 干预措施
1
Experimental
Single dose of 750mg of intravenous AZD9742 in healthy elderly volunteers
干预措施: AZD9742 (Drug)
2
Placebo Comparator
Sterile 5% dextrose solution
干预措施: Placebo (Drug)
结局指标
主要结局
To assess the safety and tolerability of a single intravenous dose of AZD9742 in healthy elderly adults.
时间窗: The screening period is up to 28 days. Residential period will be a total of 5 days. Follow up will occur between 5 and 10 days after discharge.
Adverse events, vital signs, electrocardiograms, telemetry, physical exams, and clinical laboratory assessments will be assessed prior to, during, and after treatment
次要结局
- To evaluate the pharmacokinetics of a single intravenous dose of AZD9742 in healthy elderly volunteers(Blood and urine samples will be collected for the 4 days while in residence.)
研究者
研究点 (1)
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