Status:
COMPLETED
A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes
Lead Sponsor:
Fontem US LLC
Collaborating Sponsors:
Fontem Ventures BV
Conditions:
Healthy Volunteers
Eligibility:
All Genders
21-65 years
Phase:
NA
Brief Summary
This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfac...
Eligibility Criteria
Inclusion
- smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
- tested positive for urine cotinine (≥ 200 ng/mL) at Screening
- exhaled carbon monoxide \> 10 ppm (parts per million) at Screening
Exclusion
- relevant illness history
- relevant medication use
- body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening
- allergy to propylene glycol or glycerin
- use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
- use of any prescription smoking cessation treatments within 3 months prior to Check-in
- smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
- planning to quit smoking during the study
- female subjects who are pregnant, lactating, or intend to become pregnant
Key Trial Info
Start Date :
December 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 31 2020
Estimated Enrollment :
39 Patients enrolled
Trial Details
Trial ID
NCT04429932
Start Date
December 1 2019
End Date
January 31 2020
Last Update
June 7 2021
Active Locations (1)
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1
Celerion
Lincoln, Nebraska, United States, 68502