Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Nerudia Ltd | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| myBluTM Formulation 1 Oral cavity and lungs | Experimental | This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 |
|
| myBluTM Formulation 2 Oral cavity and lungs | Experimental | This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 |
|
| myBluTM Formulation 1 Brain | Experimental | This group was used for measuring brain endpoints after administration of Formulation 1 |
|
| myBluTM Formulation 2 Brain | Experimental | This group was used for measuring brain endpoints after administration of Formulation 2 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| myBluTM Formulation 1 | Other | 1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs |
|
| 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 |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PET Centre, Uppsala University Hospital | Uppsala | SE-751 85 | Sweden |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 30, 2020 | Jul 8, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| myBluTM Formulation 2 | Other | 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 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 |
| FG002 | 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 |
| FG003 | 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 |
| COMPLETED |
|
| NOT COMPLETED |
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | 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 |
| BG003 | 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 |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Mean | Standard Deviation | Percentage of nicotine | 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 | Posted | Mean | Standard Deviation | Percentage of nicotine | 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 | 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. | Posted | Number | Percentage of nicotine | 30 minutes |
|
|
7 days
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 6 | 0 | 6 | 3 | 6 |
| EG001 | 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 | 0 | 5 | 0 | 5 | 1 | 5 |
| EG002 | 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 | 0 | 3 | 0 | 3 | 2 | 3 |
| EG003 | 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 | 0 | 1 | 0 | 1 | 0 | 1 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Catheter site hypo-aesthesia | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
| |
| Pain | General disorders | MedDRA (Unspecified) | Non-systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Simon McDermott | ImperialBrands PLC | +44 (0)117 332 0225 | simon.mcdermott@uk.imptob.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 14, 2020 | Jul 8, 2022 | SAP_001.pdf |
| Male |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
|
|
|