An Exploratory PET-study of Deposition, Disposition and Brain Uptake of [11C]Nicotine After Inhalation of 2 Nicotine Formulations Via the myBluTM E-cigarette in Smokers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Lung PET
研究概览
简要总结
This is a single-center, exploratory positron emission tomography (PET) study of deposition, disposition and brain uptake [11C]nicotine when given to smokers as two different formulations via mybluTM e-cigarette system.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index ≥18.0 and ≤ 30.0 kg/m2
- •Habitual daily cigarette smoker
- •Women have to be of non-child bearing potential
排除标准
- •History of any clinically significant disease
- •Relevant concomitant medication
- •Any clinically significant condition
- •Malignancy within the past 5 years
- •Positif for HIV, hepatitis B or C
- •Untreated hypertension
- •Previous participation to a PET-study or other nuclide medical study
- •Previous exposure to significant radiation
- •Negative results of the modified Allen test on both arms at screening
- •Alcohol or drug abuse
研究组 & 干预措施
myBluTM Formulation 1 Oral cavity and lungs
This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1
干预措施: myBluTM Formulation 1 (Other)
myBluTM Formulation 2 Oral cavity and lungs
This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2
干预措施: myBluTM Formulation 2 (Other)
myBluTM Formulation 1 Brain
This group was used for measuring brain endpoints after administration of Formulation 1
干预措施: myBluTM Formulation 1 (Other)
myBluTM Formulation 2 Brain
This group was used for measuring brain endpoints after administration of Formulation 2
干预措施: myBluTM Formulation 2 (Other)
结局指标
主要结局
Lung PET
时间窗: 40 minutes
Peak accumulation of \[11C\]nicotine deposited in the lung during 40 minutes after product administration, using dynamic PET Digital Imaging and Communications in Medicine (DICOM) images over the lungs
Brain PET
时间窗: 30 minutes
Peak accumulation of nicotine deposited in the brain during 30 minutes after product administration, using dynamic PET Digital Imaging and Communications in Medicine (DICOM) images over the brain
Oral Cavity PET
时间窗: 40 minutes
Peak accumulation of nicotine deposited in the oral cavity during 40 minutes after product administration, using dynamic PET Digital Imaging and Communications in Medicine (DICOM) images over the oral cavity
次要结局
未报告次要终点