A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes

An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers

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 satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers.

Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.

Inclusion Criteria:

• 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 Criteria:

• 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