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

Study Overview
=================
Brief Summary
-----------------
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.

Official Title
-----------------
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

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Other: myBluTM Formulation 1
* Other: myBluTM Formulation 2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body mass index ≥18.0 and ≤ 30.0 kg/m2 Habitual daily cigarette smoker Women have to be of non-child bearing potential Exclusion Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: myBluTM Formulation 1 Oral cavity and lungs<br>This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 | Other: myBluTM Formulation 1<br>* 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs<br>|
| Experimental: myBluTM Formulation 2 Oral cavity and lungs<br>This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 | Other: myBluTM Formulation 2<br>* 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs<br>|
| Experimental: myBluTM Formulation 1 Brain<br>This group was used for measuring brain endpoints after administration of Formulation 1 | Other: myBluTM Formulation 1<br>* 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs<br>|
| Experimental: myBluTM Formulation 2 Brain<br>This group was used for measuring brain endpoints after administration of Formulation 2 | Other: myBluTM Formulation 2<br>* 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung PET | 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 | 40 minutes | 
| Oral Cavity PET | 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 | 40 minutes | 
| Brain PET | 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 | 30 minutes |