A Phase I, Single-centre, Randomised, Double-blind, Parallel Group, Placebo-controlled Study to Assess the Safety, Tolerability and Pharmacokinetics After Multiple Oral Doses of AZD2066 in Japanese Healthy Male Subjects
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- AstraZeneca
- 入组人数
- 132
- 试验地点
- 1
- 主要终点
- Safety and tolerability 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, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.
详细描述
The purpose of this study is to investigate the safety, tolerability and pharmacokinetics of AZD2066 when given as multiple doses to Japanese healthy male subjects. Four (4) consecutive multiple-ascending panels are planned. Subjects will start with an initial single dose that is followed by a wash-out period of 48 hours to adequately define the single-dose pharmacokinetics. For the third and forth dose panels, the wash-out period will be extended to be 96 hours to evaluate the safety of subjects. Thereafter the subjects will be dosed once daily for 10 days. Furthermore, the study has been expanded to include two additional panels with increment of dose during the multiple dosing period (12 days) in order to obtain sufficient information on safety and tolerability of multiple dosing of AZD2066 in Japanese subjects at higher levels of exposure. Ten (10) subjects will be allocated to each dose panel and randomized to receive either AZD2066 or placebo.
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
- Male
- 接受健康志愿者
- 是
入选标准
- •Provision of signed informed consent
- •Healthy Japanese males as judged by the investigator
- •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) within first 2 weeks before first administration of study drug.
研究组 & 干预措施
1
4 dose panels receiving a specified volume of AZD2066 oral solution once daily for 11 days
干预措施: AZD2066 (Drug)
2
Included in each dose panel
干预措施: Placebo (Drug)
结局指标
主要结局
Safety and tolerability 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
- Investigate pharmacokinetic profile (including dose proportionality, degree of accumulation and time dependancy) of AZD2066 in Japanese healthy male subjects(Blood sampling at defined timepoints during residential period and follow-up)
- Investigate CNS effects of AZD2066 in Japanese healthy male subjects(Psychometric test battery performed at defined timepoints during the residential period. Test on day -1 for training purposes.)