search
Back to results

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

Primary Purpose

Healthy Volunteers

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
myBluTM Formulation 1
myBluTM Formulation 2
Sponsored by
Imperial Brands PLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Healthy Volunteers

Eligibility Criteria

50 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • PET Centre, Uppsala University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

myBluTM Formulation 1 Oral cavity and lungs

myBluTM Formulation 2 Oral cavity and lungs

myBluTM Formulation 1 Brain

myBluTM Formulation 2 Brain

Arm Description

This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1

This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2

This group was used for measuring brain endpoints after administration of Formulation 1

This group was used for measuring brain endpoints after administration of Formulation 2

Outcomes

Primary Outcome Measures

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
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
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

Secondary Outcome Measures

Full Information

First Posted
February 23, 2021
Last Updated
July 8, 2022
Sponsor
Imperial Brands PLC
Collaborators
Nerudia Ltd
search

1. Study Identification

Unique Protocol Identification Number
NCT04780815
Brief 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
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
March 16, 2020 (Actual)
Primary Completion Date
November 17, 2020 (Actual)
Study Completion Date
November 17, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Imperial Brands PLC
Collaborators
Nerudia Ltd

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy Volunteers

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
myBluTM Formulation 1 Oral cavity and lungs
Arm Type
Experimental
Arm Description
This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1
Arm Title
myBluTM Formulation 2 Oral cavity and lungs
Arm Type
Experimental
Arm Description
This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2
Arm Title
myBluTM Formulation 1 Brain
Arm Type
Experimental
Arm Description
This group was used for measuring brain endpoints after administration of Formulation 1
Arm Title
myBluTM Formulation 2 Brain
Arm Type
Experimental
Arm Description
This group was used for measuring brain endpoints after administration of Formulation 2
Intervention Type
Other
Intervention Name(s)
myBluTM Formulation 1
Intervention Description
1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs
Intervention Type
Other
Intervention Name(s)
myBluTM Formulation 2
Intervention Description
1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs
Primary Outcome Measure Information:
Title
Lung PET
Description
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
Title
Oral Cavity PET
Description
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
Title
Brain PET
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
PET Centre, Uppsala University Hospital
City
Uppsala
ZIP/Postal Code
SE-751 85
Country
Sweden

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs