Healthy VolunteersNCT04780815
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
A study testing myBluTM Formulation 1 and myBluTM Formulation 2 in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers
- What is being tested?
- myBluTM Formulation 1 and myBluTM Formulation 2
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteSweden
- Study dates
- 16 Mar 2020to 17 Nov 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Body mass index ≥18.0 and ≤ 30.0 kg/m2
- Habitual daily cigarette smoker
- Women have to be of non-child bearing potential
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy Volunteers
- Being tested
- myBluTM Formulation 1, myBluTM Formulation 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
myBluTM Formulation 1Other
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 2Other
1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs
| Study group | Role | What they receive |
|---|---|---|
| myBluTM Formulation 1 Oral cavity and lungs | Experimental | This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 Receives: Other: myBluTM 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 Receives: Other: myBluTM Formulation 2 |
| myBluTM Formulation 1 Brain | Experimental | This group was used for measuring brain endpoints after administration of Formulation 1 Receives: Other: myBluTM Formulation 1 |
| myBluTM Formulation 2 Brain | Experimental | This group was used for measuring brain endpoints after administration of Formulation 2 Receives: Other: myBluTM Formulation 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2021
- Study start16 Mar 2020
- Primary completion17 Nov 2020
- Study completion17 Nov 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Healthy VolunteersStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imperial Brands PLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Nerudia Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04780815
- Sponsor's protocol ID
- NER 03/001
- Status last verified
- Jul 2022
- First submitted
- 23 Feb 2021
- Last updated
- 19 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04780815
- Acronym / sponsor ID
- NER 03/001
- Conditions
- Healthy Volunteers
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Imperial Brands PLCIndustry (pharma, biotech, devices)
- Collaborators
- Nerudia Ltd
- Study start
- 16 Mar 2020 (actual)
- Primary completion
- 17 Nov 2020 (actual)
- Study completion
- 17 Nov 2020 (actual)
- First posted
- 4 Mar 2021 (actual)
- Results
- Posted 19 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| myBluTM Formulation 1 Oral cavity and lungs | Experimental | Other: myBluTM Formulation 1This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1 |
| myBluTM Formulation 2 Oral cavity and lungs | Experimental | Other: myBluTM Formulation 2This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2 |
| myBluTM Formulation 1 Brain | Experimental | Other: myBluTM Formulation 1This group was used for measuring brain endpoints after administration of Formulation 1 |
| myBluTM Formulation 2 Brain | Experimental | Other: myBluTM Formulation 2This group was used for measuring brain endpoints after administration of Formulation 2 |
Who may qualify
- Ages
- 50 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Body mass index ≥18.0 and ≤ 30.0 kg/m2
- Habitual daily cigarette smoker
- Women have to be of non-child bearing potential
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| myBluTM Formulation 11-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs | Other | myBluTM Formulation 1 Brain, myBluTM Formulation 1 Oral cavity and lungs |
| myBluTM Formulation 21-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs | Other | myBluTM Formulation 2 Brain, myBluTM Formulation 2 Oral cavity and lungs |
Primary outcome
Lung PET
Time frame: 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
Time frame: 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
Time frame: 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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Screening Protocol
Pain
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing myBluTM Formulation 1 and myBluTM Formulation 2 in people with Healthy Volunteers, run by Imperial Brands PLC at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lung PET (time frame: 40 minutes). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.