NCT00735774已完成1 期
Suitability of 11C-ORM-13070 as a Positron Emission Tomography Tracer; an Open Study in Healthy Males
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Suitability of 11C-ORM-13070 as a PET tracer
研究概览
简要总结
The purpose of the study is to evaluate the suitability of 11C-ORM-13070 as a positron emission tomography tracer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Good general health ascertained by detailed medical history and physical examination
- •Males between 18 and 45 years
- •Body mass index (BMI) between 18-30 kg/m2
- •Weight 55-95 kg (inclusive)
排除标准
- •Evidence of clinically significant cardiovascular, renal, hepatic, haematological, gastro-intestinal, pulmonary, metabolic-endocrine, neurological, urogenital or psychiatric disease as judged by the investigator
- •Any condition requiring regular concomitant medication including herbal products or likely to need any concomitant medication during the study.
- •Regular consumption of more than 21 units of alcohol per week (1 unit = 4 cl spirits, about 13 g of alcohol)
- •Current use of nicotine-containing products more than 5 cigarettes or equivalent/day
- •Inability to refrain from using nicotine-containing products during the stay in the study centre
- •Inability to refrain from consuming caffeine-containing beverages during the stay in the study centre e.g. propensity in getting headache when refraining from caffeine-containing beverages
- •Blood donation or loss of significant amount of blood within 3 months prior to the screening visit
- •Abnormal 12-lead electrocardiogram (ECG) finding of clinical relevance
- •Any abnormal value of laboratory, vital signs, or physical examination, which may in the opinion of the investigator interfere with the interpretation of the test results or cause a health risk for the subject if he takes part into the study
- •Anatomical abnormality in MRI which may in the opinion of the investigator interfere with the interpretation of PET results
- •Participation in a drug study within 3 months prior to the entry into this study
- •Participation in a prior PET study
研究组 & 干预措施
11C-ORM-13070
Experimental
干预措施: 11C-ORM-13070 (Drug)
结局指标
主要结局
Suitability of 11C-ORM-13070 as a PET tracer
时间窗: 1 day
次要结局
未报告次要终点
研究者
研究点 (1)
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