A Study to Characterize Puff Topography With Use of JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
Status: | Completed |
---|---|
Conditions: | Smoking Cessation, Smoking Cessation, Tobacco Consumers |
Therapuetic Areas: | Pulmonary / Respiratory Diseases |
Healthy: | No |
Age Range: | 21 - 65 |
Updated: | 10/4/2018 |
Start Date: | August 9, 2018 |
End Date: | September 26, 2018 |
A Study to Characterize Puff Topography With Use of a JUUL 5% Electronic Nicotine Delivery Systems (ENDS) in Adult Smokers
A Study to Characterize Puff Topography with Use of a JUUL 5% Electronic Nicotine Delivery
Systems (ENDS) in Adult Smokers
Systems (ENDS) in Adult Smokers
This will be an open label study to evaluate puff topography in adult smokers using a JUUL 5%
ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of
the study is 15 days with up to a 28 days screening window.
ENDS. Up to 30 subjects will be enrolled and evaluated on Day 1 and Day 15. The duration of
the study is 15 days with up to a 28 days screening window.
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 5 to 40 manufactured combustible (menthol or non
menthol) cigarettes per day.
4. A female subject of childbearing potential must have been using 1 of the following
forms of contraception and agree to continue using it through completion of the study
5. Provides voluntary consent to participate in this study documented on the signed
informed consent form.
Key Exclusion Criteria:
1. Has a clinically significant abnormal finding on the physical examination, medical
history, vital signs, ECG, or clinical laboratory results, in the opinion of the PI.
2. Has a body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening.
3. Has a history of drug or alcohol abuse within 24 months of Day 1.
4. If female, the subject is pregnant, lactating, or intends to become pregnant during
the time period from Screening through the end of study.
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