Assessment of JUUL 5% nicotine salt based Electronic Nicotine Delivery System (ENDS) products, when used by healthy adult smokers
A Six-sequence, Randomized Crossover Study Comparing Nicotine Pharmacokinetics of Traditional Cigarettes and JUUL 5% Nicotine Salt Based ENDS Products, in Healthy Adult Smokers
JUUL Labs
24 participants
Jul 16, 2017
Interventional
Conditions
Summary
This is an open label, randomized, 6-sequence crossover study. The study will enrol 24 evaluable healthy adult smokers. Subjects will be screened for participation up to 28 days before dosing. Subjects will be trained in the use of study product following completion of screening procedures. Subjects meeting all entry criteria at screening will be admitted to the clinic on Day 1. Eligible subjects will remain at the clinic until all study-related assessments are completed. Subjects will receive a total of six “doses” of nicotine, delivered in a randomized order. ere will be a washout of at least 120 minutes between the first inhalation of each product. A product and its associated assessments will be referred to in this protocol as a “dosing period”. The use of the term “dose” in this protocol does not mean to imply that the products are intended as therapeutics or smoking cessation products.Treatments to be administered in the current study are: A. Tobacco flavored JUUL 5% nicotine salt based ENDS product, consumed in 10 puffs. B. Mint flavored JUUL 5% nicotine salt based ENDS product, consumed in 10 puffs. C. Tobacco flavored traditional Pall Mall cigarette, consumed in 10 puffs. D. Mint flavored traditional Newport 100s cigarette, consumed in 10 puffs. E. Tobacco flavored JUUL 5% nicotine salt based ENDS product, consumed in ad libitum puffs. F.Tobacco flavored traditional Pall Mall cigarette, consumed in ad libitum puffs (if the cigarette is completed in less than 4.5 minutes, another cigarette will be made available to be smoked until the end of the 4.5-minute period). Treatments will be administered open label. For Treatments A - D, the subject will be asked to inhale 10 times, with 30 seconds between inhalations, using the assigned product. With each inhalation procedure, subjects will be instructed to breathe in gently (“puff”) for 3 seconds, remove the JUUL from their mouth, and then inhale prior to exhaling. Total time for administration will be 4.5 minutes. For Treatments E and F, the subject will be asked to consume the product using ad libitum puffs over a period of 4.5 minutes. For Treatment F, if the cigarette is completed in less than 4.5 minutes another cigarette will be made available to be smoked until the end of the 4.5-minute period. PK samples will be collected up to 5 minutes prior to initiation of the first inhalation (- 5 min); 0.0, 1.5, 3.0, 5.0, 7, 10, 12, 15, 30 and 60 minutes after initiation of the first inhalation in each dosing period. Carbon Monoxide levels in expired air will be measured 5-10 minutes prior to and 15-20 minutes after initiating each dose period. The CO measure may be conducted in a sub-set of subjects. A product evaluation questionnaire will be completed after collection of the 30-minute PK sample in all dosing periods. Subjects will be discharged after completion of safety and PK evaluations for the final dosing period.
Eligibility
Inclusion Criteria5
- Male or female aged 18 to 45 years of age inclusive.
- Body Mass Index (BMI) between 18 to 32kg / m2 inclusive.
- Healthy on the basis of medical history and screening assessments, in the opinion of the Investigator.
- Current smoker of at least 7 cigarettes per week on average.
- Able to participate, and willing to give written informed consent and to comply with the study restrictions.
Exclusion Criteria11
- 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.
- Regular use of e-cigarettes only, with no regular use of cigarettes (dual cigarette / e-cigarette users are permitted).
- 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 Day 1.
- Blood or plasma donation of > 500 mL within 1 month prior to Day 1.
- Positive urine pregnancy test at screening or Day 1 in female subject.
- 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 subject in this study.
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Interventions
Subjects will receive a total of six “doses” of nicotine (1-3 mg), delivered in a randomized order. There will be a washout of at least 120 minutes between the first inhalation of each product. The use of the term “dose” in this protocol does not mean to imply that the products are intended as therapeutics or smoking cessation products - dose will be variable depending on inhalation techniques - hence concentration and puffs given for strength of ''dose''.. Treatments to be administered in the current study are: A. Tobacco flavored JUUL 5% nicotine salt (1-3 mg) based ENDS product, consumed in 10 puffs. B. Mint flavored JUUL 5% nicotine salt (1-3 mg) based ENDS product, consumed in 10 puffs. C. Tobacco flavored traditional Pall Mall cigarette (1-3 mg) , consumed in 10 puffs. D. Mint flavored traditional Newport 100s cigarette (1-3 mg) , consumed in 10 puffs. For Treatments A - D, the subject will be asked to inhale 10 times, with 30 seconds between inhalations, using the assigned product. With each inhalation procedure, subjects will be instructed to breathe in gently (“puff”) for 3 seconds, remove the JUUL from their mouth, and then inhale prior to exhaling. Total time for administration will be 4.5 minutes. E. Tobacco flavored JUUL 5% nicotine salt based ENDS product, consumed in ad libitum puffs for a period of 4.5 minutes. F. Tobacco flavored traditional Pall Mall cigarette, consumed in ad libitum puffs (if the cigarette is completed in less than 4.5 minutes, another cigarette will be made available to be smoked until the end of the 4.5-minute period). All treatments delivered once on the same day. all product administration will occur under medical supervision, compliance is not expected to present a problem.
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ACTRN12618000800224