Trial Outcomes & Findings for 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 (NCT NCT04780815)

Last Updated: 2023-05-19

Results Overview

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

Recruitment status

COMPLETED

Study phase

Target enrollment

16 participants

Primary outcome timeframe

40 minutes

Results posted on

2023-05-19

Participant Flow

Participant milestones

Participant milestones
Measure	myBluTM Formulation 1 Oral Cavity and Lungs This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 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 Oral Cavity and Lungs This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 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	myBluTM Formulation 1 Brain This group was used for measuring brain endpoints after administration of Formulation 1 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 Brain This group was used for measuring brain endpoints after administration of Formulation 2 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
Overall Study STARTED	6	5	3	2
Overall Study COMPLETED	6	5	3	1
Overall Study NOT COMPLETED	0	0	0	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	myBluTM Formulation 1 Oral Cavity and Lungs n=6 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 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 Oral Cavity and Lungs n=5 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 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	myBluTM Formulation 1 Brain n=3 Participants This group was used for measuring brain endpoints after administration of Formulation 1 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 Brain n=1 Participants This group was used for measuring brain endpoints after administration of Formulation 2 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	Total n=15 Participants Total of all reporting groups
Age, Continuous	59.7 years STANDARD_DEVIATION 2.8 • n=5 Participants	54.2 years STANDARD_DEVIATION 3.1 • n=7 Participants	61.3 years STANDARD_DEVIATION 5.5 • n=5 Participants	54.0 years STANDARD_DEVIATION 0.0 • n=4 Participants	57.8 years STANDARD_DEVIATION 4.4 • n=21 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	4 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	12 Participants n=21 Participants
Sex: Female, Male Male	2 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	3 Participants n=21 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	3 Participants n=5 Participants	1 Participants n=4 Participants	15 Participants n=21 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants	0 Participants n=21 Participants

PRIMARY outcome

Timeframe: 40 minutes

Outcome measures

Outcome measures
Measure	myBluTM Formulation 1 Oral Cavity and Lungs n=4 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 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 Oral Cavity and Lungs n=5 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 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
Lung PET	35.5 Percentage of nicotine Standard Deviation 9.1	31.0 Percentage of nicotine Standard Deviation 9.6

PRIMARY outcome

Timeframe: 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

Outcome measures

Outcome measures
Measure	myBluTM Formulation 1 Oral Cavity and Lungs n=5 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 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 Oral Cavity and Lungs n=5 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 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
Oral Cavity PET	9.26 Percentage of nicotine Standard Deviation 2.44	1.52 Percentage of nicotine Standard Deviation 1.39

PRIMARY outcome

Timeframe: 30 minutes

Population: Four subjects underwent a brain \[11C\]nicotine PET/CT scan, but the tracer inhalation failed for two of the subjects. Consequently, only two \[11C\]nicotine scans could be used for evaluation, one after inhalation of Formulation 1 and one after inhalation of Formulation 2.

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

Outcome measures

Outcome measures
Measure	myBluTM Formulation 1 Oral Cavity and Lungs n=1 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 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 Oral Cavity and Lungs n=1 Participants This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 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
Brain PET	4.50 Percentage of nicotine	5.14 Percentage of nicotine

Adverse Events

myBluTM Formulation 1 Oral Cavity and Lungs

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

myBluTM Formulation 2 Oral Cavity and Lungs

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

myBluTM Formulation 1 Brain

Serious events: 0 serious events

Other events: 2 other events

Deaths: 0 deaths

myBluTM Formulation 2 Brain

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	myBluTM Formulation 1 Oral Cavity and Lungs n=6 participants at risk This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 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 Oral Cavity and Lungs n=5 participants at risk This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 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	myBluTM Formulation 1 Brain n=3 participants at risk This group was used for measuring brain endpoints after administration of Formulation 1 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 Brain n=1 participants at risk This group was used for measuring brain endpoints after administration of Formulation 2 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
Respiratory, thoracic and mediastinal disorders Cough	50.0% 3/6 • 7 days	20.0% 1/5 • 7 days	33.3% 1/3 • 7 days	0.00% 0/1 • 7 days
General disorders Catheter site hypo-aesthesia	0.00% 0/6 • 7 days	0.00% 0/5 • 7 days	33.3% 1/3 • 7 days	0.00% 0/1 • 7 days
General disorders Pain	0.00% 0/6 • 7 days	0.00% 0/5 • 7 days	33.3% 1/3 • 7 days	0.00% 0/1 • 7 days

Additional Information

Simon McDermott

ImperialBrands PLC

Phone: +44 (0)117 332 0225

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place