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

Not Applicable

Completed

• Conditions: Healthy Volunteers
• Interventions: Other: myBluTM Formulation 1; Other: myBluTM Formulation 2

• Registration Number: NCT04780815
• Lead Sponsor: Imperial Brands PLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2020-03-16
• Primary Completion: 2020-11-17
• Study Completion: 2020-11-17
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-03-02
• Study First Posted: 2021-03-04
• Status Verified: 2022-07
• Results First Submitted: 2022-07-08
• Results First Submitted QC: 2022-07-08
• Last Update Submitted: 2022-07-08
• Results First Posted: 2023-05-19
• Last Update Posted: 2023-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
myBluTM Formulation 1 Brain	myBluTM Formulation 1	This group was used for measuring brain endpoints after administration of Formulation 1
myBluTM Formulation 2 Oral cavity and lungs	myBluTM Formulation 2	This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2
myBluTM Formulation 2 Brain	myBluTM Formulation 2	This group was used for measuring brain endpoints after administration of Formulation 2
myBluTM Formulation 1 Oral cavity and lungs	myBluTM Formulation 1	This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1

Primary Outcome Measures

Name	Time	Method
Lung PET	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	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	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

Trial Locations

Locations (1)

PET Centre, Uppsala University Hospital; 🇸🇪 Uppsala, Sweden