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

Imperial Brands PLC16 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

myBluTM Formulation 1OTHER

1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs

myBluTM Formulation 2OTHER

1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs

Eligibility

Sex: ALLMin age: 50 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

PET Centre, Uppsala University Hospital

Uppsala, Sweden

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 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

Time frame: 30 minutes

Data from ClinicalTrials.gov

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