A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics of AZD2066 in Young and Elderly Healthy Subjects After Oral Multiple Ascending Doses
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 110
- 试验地点
- 1
- 主要终点
- Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG
研究概览
简要总结
The purpose of this study is to investigate the safety and tolerability of AZD2066 using multiple escalating dose panels. There will be separate panels for young healthy volunteers and elderly healthy volunteers. Each panel will contain 10 volunteers who will randomly receive AZD2066 or placebo. One panel will be run at a time with a fixed dose given. After the completion of each panel, a Safety Review Committee will decide if the study can proceed to the next dose panel.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Provision of signed informed consent
- •Clinically normal physical findings and laboratory values as judged by the investigator and a normal resting ECG.
排除标准
- •History of somatic disease/condition, which may interfere with the objectives of the study, as judged by the investigator.
- •History of previous or ongoing psychiatric disease/condition including psychosis, affective disorder, anxiety disorder, borderline state and personality disorder.
- •Intake of medicine (except occasional paracetamol or nasal spray) within first 2 weeks before first administration of study drug.
研究组 & 干预措施
1
Oral solution.
干预措施: AZD2066 (Drug)
2
Oral solution
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability of AZD2066 by assessment of vital signs, laboratory variables and ECG
时间窗: Assessments taken at visit 1 (enrolment), defined time points pre dose and post dose during visit 2 (residential period): days -1 through to day 15 and follow up visit 3
次要结局
- Safety and tolerability of AZD2066 by assessment of adverse events(Non serious adverse events will be collected from the start of Visit 2 until the end of the study. Serious adverse events will be collected from signing of consent until end of study.)
- Investigate PK profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 (and possible relevant metabolites).(PK sampling taken at defined timepoints during residential period and follow-up.)
- Investigate CNS effects of AZD2066(Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.)