A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette, for up to 56 days. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers.

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics (PK) sub-study.

Subjects are randomized to either continue smoking conventional cigarettes, or switch to use the myblu e-cigarette. Within the "myblu" arm, subjects were assigned to one of four variants of the myblu e-cigarette, having different flavors and nicotine strengths. Initial product assignment for each subject was based on preference as a method to enhance compliance. To further improve compliance through Day 56, subjects may have been allowed to choose to switch to another variant of the myblu e-cigarette, or to continue using the same e-liquid selected initially.

Inclusion Criteria:

• Having smoked ≥5 manufactured combustible cigarettes per day for at least one year
• Exhaled carbon monoxide level of >10 ppm at screening
• Tested positive for urinary cotinine (approximately 200 ng/mL) at screening

Exclusion Criteria:

• Relevant illness history
• Relevant medication use
• Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
• Allergy to propylene glycol or glycerin
• Use of nicotine-containing products other than manufactured cigarettes
• Use of prescription smoking cessation treatments
• Smokers who draw smoke into their mouth and throat but do not inhale
• Intent or desire to stop smoking
• Female subjects who are pregnant, lactating, or intend to become pregnant