Healthy Volunteers
Conditions
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.
Interventions
OTHERmyBluTM 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
OTHERmyBluTM 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
Sponsors
Nerudia Ltd
Imperial Brands PLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
Countries
Sweden
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 6 |
| 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 | 5 |
| 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 | 3 |
| 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 | 1 |
| Total | 15 |
Baseline characteristics
| Characteristic | myBluTM Formulation 1 Oral Cavity and Lungs | Total | myBluTM Formulation 2 Brain | myBluTM Formulation 1 Brain | myBluTM Formulation 2 Oral Cavity and Lungs |
|---|---|---|---|---|---|
| Age, Continuous | 59.7 years STANDARD_DEVIATION 2.8 | 57.8 years STANDARD_DEVIATION 4.4 | 54.0 years STANDARD_DEVIATION 0 | 61.3 years STANDARD_DEVIATION 5.5 | 54.2 years STANDARD_DEVIATION 3.1 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 6 Participants | 15 Participants | 1 Participants | 3 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 12 Participants | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Male | 2 Participants | 3 Participants | 0 Participants | 0 Participants | 1 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 5 | 0 / 3 | 0 / 1 |
| other Total, other adverse events | 3 / 6 | 1 / 5 | 2 / 3 | 0 / 1 |
| serious Total, serious adverse events | 0 / 6 | 0 / 5 | 0 / 3 | 0 / 1 |
Outcome results
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
Time frame: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| myBluTM Formulation 1 Oral Cavity and Lungs | Brain PET | 4.50 Percentage of nicotine |
| myBluTM Formulation 2 Oral Cavity and Lungs | Brain PET | 5.14 Percentage of nicotine |
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
Time frame: 40 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| myBluTM Formulation 1 Oral Cavity and Lungs | Lung PET | 35.5 Percentage of nicotine | Standard Deviation 9.1 |
| myBluTM Formulation 2 Oral Cavity and Lungs | Lung PET | 31.0 Percentage of nicotine | Standard Deviation 9.6 |
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
Time frame: 40 minutes
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| myBluTM Formulation 1 Oral Cavity and Lungs | Oral Cavity PET | 9.26 Percentage of nicotine | Standard Deviation 2.44 |
| myBluTM Formulation 2 Oral Cavity and Lungs | Oral Cavity PET | 1.52 Percentage of nicotine | Standard Deviation 1.39 |