N/A
Completed N=16
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
Healthy Volunteers
Source: ClinicalTrials.gov NCT04780815 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Lung PET — 35.5; 31.0 Percentage of nicotine
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Lung PET |
35.5; 31.0 | — |
| PRIMARY Oral Cavity PET |
9.26; 1.52 | — |
| PRIMARY Brain PET |
4.50; 5.14 | — |
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
Data sourced from ClinicalTrials.gov (NCT04780815). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.