Comparing the Pharmacokinetics of Nicotine Salt Based ENDS in Healthy Smokers

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based Electronic Nicotine Delivery System (ENDS Products), in Healthy Adult Smokers

A Ten Sequence, Open Label, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of JUUL 1.7% and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers.

E-cigarettes may be an acceptable alternative to traditional cigarette smoking. In utilizing vaporization rather than combustion, the generation and inhalation of smoke and carbon monoxide (CO) may be reduced or avoided. JUUL has developed several nicotine based liquid blends for use in e-cigarettes. This study will provide an understanding of the levels of nicotine obtained with use of the company's 1.7% and 5% ENDS products.

Inclusion Criteria:

• Male or female aged 18 to 60 years of age inclusive.
• Current smoker or e-cigarette user:
• Able to participate, and willing to give written informed consent and to comply with the ° study restrictions.

Exclusion criteria:

• Clinically significant abnormality on screening ECG.
• Sustained blood pressure recordings at screening of < 90 mmHg or > 150 mmHg for systolic blood pressure, or < 50 mmHg or > 90 mmHg for diastolic blood pressure.
• Sustained resting heart rate of > 100 or < 40 beats per minute at screening.
• Positive result for urine drugs of abuse test or alcohol breath test at screening.
• Clinically significant abnormality in laboratory test results at screening, in the opinion of the Investigator.
• Positive urine pregnancy test at screening or Assessment Days in female subjects of child bearing potential.
• Any clinically significant concomitant disease or conditions.