NL-OMON32334尚未招募不适用
A phase 1, single centre, single dose, double-blind, double-dummy, four-way crossover, placebo-controlled, randomized study to investigate the effects of AZD7325 on sedation, cognition and EEG in comparison with lorazepam in healthy male volunteers. - Effects of AZD7325 on sedation, cognition and EEG.
Astra Zeneca0 个研究点目标入组 16 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 16
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Provision of written informed consent
- •2. Healthy male subjects aged 18 to 55 years (extremes inclusive) on sceening
- •3. Body Mass Index (BMI) >= 18 and <= 30 kg/m2
排除标准
- •1. Clinically relevant disease and/or abnormalities (past or present) which in the opinion of the investigator, may either put the subject at risk to participate in the study or may influence the results of the study or the subject*s ability to participate in the study
- •2. Psychiatric, medical, and surgical history that may interfere with the objectives of the study
- •3. Subject*s partner is planning pregnancy within 3 months of last dosing
- •4. Significant illness, as judged by the investigator, within 2 weeks of the first study day
- •5. Clinically relevant abnormalities in physical examinations, vital signs, clinical
- •chemistry, thyroid function test, hematology or urinalysis at screening as judged by the investigator and/or sponsor
- •6. ECG with a QTcF interval of >450 or <360msec at screening
- •7. History of clinically significant arrhythmias (including II degree atrioventricular block and Wolff-Parkinson-White Syndrome)
- •8. Any other clinically significant abnormal baseline ECG and/or abnormalities in ECG
- •as judged by the investigator and/or sponsor at the screening visit
- •9. Positive human immune deficiency virus (HIV), Hepatitis B or Hepatitis C test
- •10. Current manifestation of any clinically significant allergic disorder with the exception of seasonal allergies
- •11. Use of any medication or herbal preparation within 14 days of the first study day through the Follow-up Visit other than paracetamol (up to 3g/day) and incidental use of prescription or non-prescription medication approved by the investigator.
- •12. Enrollment in another concurrent investigational study or intake of an investigational drug within 3 months prior to the start of the study or more than 4 times a year.
- •13. Donation of blood in the past 3 months.
- •14. Smoking in excess of 5 cigarettes per day or the equivalent within 28 days prior to the first study day or inability to refrain from smoking from 22:00 prior to each study day
- •15. Current regular user (including *recreational uses*) of any illicit drugs or history of drug or alcohol abuse. Subjects who have a positive drug screen at screening are excluded.
- •16. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff and staff at the CPU)
- •17. Prior randomization in a trial with AZD7325
- •18. Inability to understand or cooperate with the requirements of this study
研究者
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