Status:
COMPLETED
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
Lead Sponsor:
Imperial Brands PLC
Collaborating Sponsors:
Nerudia Ltd
Conditions:
Healthy Volunteers
Eligibility:
All Genders
50-65 years
Phase:
NA
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 mybluT...
Eligibility Criteria
Inclusion
- Body mass index ≥18.0 and ≤ 30.0 kg/m2
- Habitual daily cigarette smoker
- Women have to be of non-child bearing potential
Exclusion
- 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
Key Trial Info
Start Date :
March 16 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 17 2020
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04780815
Start Date
March 16 2020
End Date
November 17 2020
Last Update
May 19 2023
Active Locations (1)
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1
PET Centre, Uppsala University Hospital
Uppsala, Sweden, SE-751 85