NCT00886067已完成1 期
An Open-label Positron Emission Tomography (PET) Study Using 2 [18F] F A85380 to Determine α4β2 Neuronal Nicotinic Receptor (NNR) Occupancy of AZD1446 After Oral Administration to Male and Non-fertile Female (Non-nicotine Users) Healthy Volunteers
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
- 11
- 试验地点
- 1
- 主要终点
- Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.
研究概览
简要总结
The primary purpose is to study the occupancy at the α4β2 neuronal nicotinic receptor's (NNRs) and to determine the relation between plasma concentration of AZD1446 and the occupancy at α4β2 NNRs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- None
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
- •Physically healthy volunteers
- •Body weight between 50 to 100 kg and body mass index (BMI) between 19 and 30 kg/m2
排除标准
- •History of any clinically significant disease or disorder
- •History of severe allergy/hypersensitivity reactions
- •Participation in a PET examination as part of a scientific study during the past twelve months
研究组 & 干预措施
2-[18F]-F-A85380
Experimental
Single microdose
干预措施: 2-[18F]-F-A85380 (Radiation)
AZD1446
Experimental
Single oral administration
干预措施: AZD1446 (Drug)
结局指标
主要结局
Determine whether and to what extent AZD1446 can displace radioligand 2-[18F]-F-A85380 from binding to α4β2 neuronal nicotinic receptors (NNRs) and to describe the relationship between plasma concentrations of AZD1446 and its occupancy at α4β2 NNRs.
时间窗: One PET assessment on baseline day and one PET assessment at the drug treatment day
Plasma concentration (Cmax, tmax, AUC)
时间窗: During time period of the PET assessment
次要结局
- Safety and tolerability (AEs, vital signs, lab)(During the whole study)
研究者
研究点 (1)
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