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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Other: myBluTM Formulation 1; Other: myBluTM Formulation 2

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Uppsala, Sweden, SE-751 85
    • PET Centre, Uppsala University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: myBluTM Formulation 1 Oral cavity and lungs; This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1	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
Experimental: myBluTM Formulation 2 Oral cavity and lungs; This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2	Other: 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
Experimental: myBluTM Formulation 1 Brain; This group was used for measuring brain endpoints after administration of Formulation 1	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
Experimental: myBluTM Formulation 2 Brain; This group was used for measuring brain endpoints after administration of Formulation 2	Other: 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

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Arterial blood radioactivity vs time profile	Single-dose pharmacokinetics of 11C-labelled nicotine in arterial blood, by measuring radioactivity in arterial blood in discrete samples	2, 4, 6, 8, 10, 15, 20 and 30 minutes
Adverse events	Frequency, intensity and seriousness of adverse events	Day 1 to Day 7 (End of study)

Collaborators and Investigators

• Sponsor: Imperial Brands PLC
• Collaborators: Nerudia Ltd

Study record dates

Study Major Dates

• Study Start (Actual): March 16, 2020
• Primary Completion (Actual): November 17, 2020
• Study Completion (Actual): November 17, 2020

Study Registration Dates

• First Submitted: February 23, 2021
• First Submitted That Met QC Criteria: March 2, 2021
• First Posted (Actual): March 4, 2021

Study Record Updates

• Last Update Posted (Actual): May 19, 2023
• Last Update Submitted That Met QC Criteria: July 8, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Respiratory Aspiration
• Other Study ID Numbers: NER 03/001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No