NCT03700112.

Study name	An open‐label, randomized cross‐over study comparing nicotine pharmacokinetics of seven electronic cigarette products and one traditional cigarette across two delivery (10 puff and ad‐libitum) conditions, in healthy adult smokers.
Methods	Open‐label, randomized cross‐over trial Setting and recruitment not specified, New Zealand
Participants	Estimated enrolment: 24 Inclusion criteria: Male or female aged 18 to 60 years of age inclusive BMI between 18 to 35 kg/m2 inclusive Healthy based on medical history and screening assessments, in the opinion of the Investigator Current smoker of at least 8 cigarettes per day on average Has been smoking for at least 12 months prior to screening. Brief periods of non‐smoking (e.g. up to ~7 consecutive days due to illness, trying to quit, participation in a study where smoking was prohibited) are permitted at the discretion of the Investigator Able to participate, and willing to give written informed consent and comply with study restrictions Exclusion criteria: Clinically‐relevant medical or psychiatric disorder, in the opinion of the Investigator 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. If a positive urine drug test is observed, and it is believed the positive urine test is due to prescription drugs, the PI should obtain documentation that a) confirms the person's use of the prescribed medication, and b) the prescribed medication will cause a false positive drug test Clinically‐significant abnormality in laboratory test results at screening, in the opinion of the Investigator Exposure to an investigational drug in a clinical trial within 1 month prior to Assessment Day 1 Blood or plasma donation of > 500 mL within 1 month prior to Assessment Day 1 Positive urine pregnancy test at screening or Assessment Day 1 in women Any clinically‐significant concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the investigator, pose an unacceptable risk to the participant in this study
Interventions	JUUL Virginia Tobacco flavoured 5.0% ENDS; consumed using 10 puffs delivery method, ad‐libitum PMI iQOS Heat sticks ‐ Regular consumed using 10 puffs delivery method, ad‐libitum Reynolds VUSE Solo ENDS ‐ Original consumed using 10 puffs delivery method, ad‐libitum Imperial MyBlu ENDS ‐ Original consumed using 10 puffs delivery method, ad‐libitum Altria MarkTen ENDS ‐ Bold Classic consuming using 10 puffs delivery method, ad‐libitum MLV PHIX ENDS ‐ Original Tobacco consumed using 10 puffs delivery method, ad‐libitum NJOY Daily EXTRA ENDS ‐ Rich Tobacco consumed using 10 puffs delivery method, ad‐libitum Altria Marlboro combustible cigarette ‐ Red consumed using 10 puffs delivery method, ad‐libitum
Outcomes	Day 48 Outcomes: Nicotine PK parameters calculated from the individual plasma concentrations Exhaled CO Level of user satisfaction measured by Modified Product Evaluation Scale Characterize consumption of 8 x E‐cigarettes/cigarettes products by collecting total number of puffs for each e‐cigarette
Starting date	7 December 2018
Contact information	Study director: Concetta Carbonaro Responsible party: Juul Labs, Inc.
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