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NCT04780815 Clinical Trial

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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT04780815
Other study ID # NER 03/001
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 16, 2020
Est. completion date November 17, 2020

Study information
Verified date July 2022
Source Imperial Brands PLC
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 16
Est. completion date November 17, 2020
Est. primary completion date November 17, 2020
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 50 Years to 65 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Sweden PET Centre, Uppsala University Hospital Uppsala

Sponsors (2)
Lead Sponsor Collaborator
Imperial Brands PLC Nerudia Ltd

Country where clinical trial is conducted

Sweden, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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
Primary 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
Primary 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
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