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Completed

NCT Number: NCT04780815

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

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.

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Key information

Conditions

Healthy Volunteers

Age range

50 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PET Centre, Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

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

Primary outcomes

  1. 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

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Imperial Brands PLC

Industry

Collaborators

  • Nerudia Ltd

Registry information

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 4, 2021
Registry last updated
May 19, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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