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

Imperial Brands

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: myBluTM Formulation 1; Other: myBluTM Formulation 2

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT04780815

NER 03/001

Details and patient eligibility

About

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.

Enrollment: 16 patients

Sex: All

Ages: 50 to 65 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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16 participants in 4 patient groups

myBluTM Formulation 1 Oral cavity and lungs

Experimental group

Description:

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

Treatment:

Other: myBluTM Formulation 1

myBluTM Formulation 2 Oral cavity and lungs

Experimental group

Description:

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

Treatment:

Other: myBluTM Formulation 2

myBluTM Formulation 1 Brain

Experimental group

Description:

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

Treatment:

Other: myBluTM Formulation 1

myBluTM Formulation 2 Brain

Experimental group

Description:

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

Treatment:

Other: myBluTM Formulation 2