NCT01233830已完成1 期
A Phase I, Single Centre, Double-blind, Randomized, Placebo-controlled, Parallel-group Study to Assess the Safety, Tolerability and Pharmacokinetics of Oral AZD2423 Solution After Administration of Multiple Ascending Doses for 12 Days in Young and Elderly Healthy Japanese 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
- 19
- 试验地点
- 1
- 主要终点
- Number of participants with Adverse events
研究概览
简要总结
The purpose of this study is to assess safety, tolerability and pharmacokinetics of AZD2423 in young and elderly healthy Japanese volunteers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed and dated, written informed consent prior to any study specific procedures
- •Healthy Japanese male volunteers aged ≥20 to ≤45 years and healthy Japanese male and female volunteers aged ≥65 to ≤80 years with suitable veins for cannulation or repeated venipuncture
- •Have a body mass index (BMI) between ≥17 and ≤27 kg/m2, as calculated by the investigator(s), and weigh at least 45 kg and no more than 100 kg
- •Clinically normal physical findings including supine blood pressure, pulse rate, ECG, and laboratory assessments in relation to age, as judged by the investigator(s)
排除标准
- •History of any clinically significant disease or disorder which, in the opinion of the investigator(s), 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
- •Any clinically significant illness/infection or medical/surgical procedure or trauma, as judged by the investigator(s), within 3 months of the first administration of investigational product or known malignancy within the past 5 years (with the exception of successfully treated basal cell carcinoma)
研究组 & 干预措施
1
Experimental
干预措施: AZD2423 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Number of participants with Adverse events
时间窗: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Vital signs
时间窗: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Changes from baseline in systolic blood pressure, pulse rate and body temperature
Electrocardiograms
时间窗: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
Laboratory Variables (hematology, urinalysis and clinical chemistry)
时间窗: Ranging from screening visit (Visit Day 1) to follow-up visit (Visit Day 3)
次要结局
- Plasma concentration over time(Pre-dose, 20 and 40 minutes, 1, 1.5, 2, 3, 4, 6, 8, 12, 24, 36, 48, 60 and 72 hours after the first dose)
研究者
研究点 (1)
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