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 Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-16

Study Completion Date

2020-11-17

Brief Summary

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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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Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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myBluTM Formulation 1 Oral cavity and lungs

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

Group Type EXPERIMENTAL

myBluTM Formulation 1

Intervention Type 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 Oral cavity and lungs

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

Group Type EXPERIMENTAL

myBluTM Formulation 2

Intervention Type 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 1 Brain

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

Group Type EXPERIMENTAL

myBluTM Formulation 1

Intervention Type 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 Brain

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

Group Type EXPERIMENTAL

myBluTM Formulation 2

Intervention Type OTHER

1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs

Interventions

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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

Intervention Type OTHER

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

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

50 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes