NCT00912353已完成1 期
A Phase I, Single Center, Randomized, Double-Blind, Placebo-Controlled Single Ascending Oral Dose Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD7268 in Healthy Japanese Subjects
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
- 56
- 试验地点
- 1
- 主要终点
- To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings,
研究概览
简要总结
This is a Phase I, single center, randomized, double-blind, placebo-controlled single ascending oral dose study to assess the safety, tolerability and pharmacokinetics of AZD7268 in healthy Japanese subjects.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy Japanese male and female (of non-child bearing potential) subjects 20 to 45 years of age, inclusive
- •Body weight between 50 and 90 kg, inclusive, with a Body Mass Index (BMI)
- •18 to ≤ 27 kg/m2
排除标准
- •Clinically relevant disease or disorder (past or present), which in the opinion of the investigator, may either put the subject at risk because of participation in the study or influence the results or the subject's ability to participate in the study
- •Any clinically significant abnormalities in physical examination, vital signs, clinical chemistry, hematology or urinalysis results as judged by the investigator and/or sponsor
- •Smoking in excess of 5 cigarettes per day or equivalent within 30 days of Day 1
研究组 & 干预措施
AZD7268
Experimental
干预措施: AZD7268 (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
To asses the safety nature and incidence of adverse events, blood pressure, pulse rate, body temperature, physical examination, laboratory assessments (clinical chemistry, hematology, and urinalysis parameters), effects on ECG parameters, EEG recordings,
时间窗: From screening period to follow-up, 44 days (maiximum).
次要结局
- To characterize the pharmacokinetics of AZD7268 and its metabolite(s) in plasma and urine.(Blood and urine sampling from pre-dose until 72 hrs post dose.)
- To collect and store DNA for future exploratory research(One blood sampling after randomisation)
研究者
研究点 (1)
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