Identify Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% in Adult Smokers
Status: | Completed |
---|---|
Conditions: | Smoking Cessation, Tobacco Consumers |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 21 - 65 |
Updated: | 1/5/2019 |
Start Date: | March 4, 2018 |
End Date: | August 13, 2018 |
A Randomized, Open-Label, Parallel-Group Study to Characterize Biomarkers of Tobacco Exposure and Nicotine Uptake From JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
The JUUL 5% Electronic Nicotine Delivery System (ENDS) is being studied as an alternative to
combustible cigarette use. This study aims to find out how much nicotine is in the blood and
urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual
brands of combustible cigarettes and stopping smoking.
combustible cigarette use. This study aims to find out how much nicotine is in the blood and
urine of healthy adult subjects after using three JUUL 5% ENDS compared to smoking usual
brands of combustible cigarettes and stopping smoking.
This study will serve as a clinical evaluation of the exclusive use of selected JUUL ENDS,
with the purpose of gaining an understanding of toxicant exposure.
with the purpose of gaining an understanding of toxicant exposure.
Key Inclusion Criteria:
1. Healthy, adult, male or female smoker, 21 to 65 years of age.
2. Has been a smoker for at least 12 months prior to Screening.
3. Currently smokes an average of 10 cigarettes each day.
4. Has a positive urine cotinine (≥ 500 ng/mL).
5. Has an exhaled carbon monoxide (CO) > 12 ppm.
6. A female subject of childbearing potential must have been using contraception and
agree to continue using it through completion of the study:
7. Provides voluntary consent to participate in this study documented on the signed
informed consent form (ICF).
Key Exclusion Criteria
1. Has a history or presence of clinically significant conditions.
2. Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screen
3. Has a history of drug or alcohol abuse
4. Has an estimated creatinine clearance < 80 mL/minute
5. If female, the subject is pregnant, lactating, or intends to become pregnant during
the time period from Screening through the end of study.
6. Has used nicotine-containing products other than manufactured cigarettes within 14days
of screening.
7. Is planning to quit smoking during the study, planning to quit within 3 months
following Day 1
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