Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

Has a history or presence of clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.

Has a clinically significant abnormal finding on the physical examination, medical history, vital signs, ECG, or clinical laboratory results, in the opinion of the Investigator.

Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HbsAg), or hepatitis C virus (HCV).

Has had an acute illness (e.g., upper respiratory infection, viral infection) requiring treatment (including over-the-counter (OTC) remedies) within 14 days prior to Day -2 (Check-in).

Has a fever (\> 100.5°F) at Screening or Day -2 (Check-in).

Has used prescription or OTC bronchodilator medication (e.g. inhaled or oral βadrenergic agonists) to treat a chronic condition within the 12 months prior to admission;

Currently has or recently had a bladder or urinary tract infection within 30 days prior to Check-In (Day -2).

Has a body mass index (BMI) \> 40 kg/m2 or \< 18 kg/m2 at Screening.

Has a history of drug or alcohol abuse within 24 months prior to Day -2 (Check-in), as determined by the Investigator

Has diabetes mellitus, asthma, or chronic obstructive pulmonary disease (COPD).

Has a systolic blood pressure \< 90 mmHg or \> 150 mmHg, diastolic blood pressure \< 40 mmHg or \> 95 mmHg, or heart rate \< 40 bpm or \> 99 bpm at Screening.

Has a post-bronchodilator forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) ratio \< 0.7 and FEV1 \< 80% of predicted at Screening.

Has a post-bronchodilator FEV1 increase \> 12% and \> 200 mL from pre- to post-bronchodilator at Screening.

Has experienced an allergic reaction following previous e-cigarette use or with exposure to any primary components of the JUUL liquids (benzoic acid, propylene glycol and glycerol).

Has an estimated creatinine clearance \< 70 mL/minute (using the Cockcroft-Gault equation) at Screening.

Has a positive urine screen for drugs of abuse or positive urine/breath screen for alcohol at Screening or Day -2 (Check-in).

If female, the subject is pregnant, lactating, or intends to become pregnant during the time period from Screening through the end of study.

Has used medications known to interact with cytochrome P450 (CYP) 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives of the drug, whichever is longer, prior to Day -2 (Check-in).

Has used nicotine-containing products other than manufactured cigarettes (e.g., ENDS, roll-your-own cigarettes, bidis, snuff, nicotine inhaler, pipe, cigar, chewing tobacco, hookah/shisha, nicotine patch, nicotine spray, nicotine lozenge, or nicotine gum) within 30 days prior to Day -2 (Check-in), except as required per protocol (e.g., the brief product trial at Screening).

Has a prior history of JUUL product use within (≤) 30 days prior to Screening.

Has used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or buproprion (Zyban®) within 3 months prior to Day -2 (Check-in).

Is a self-reported puffer (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).

Is planning to quit smoking during the study or within 3 months following Day 1, or is postponing a quit attempt in order to participate in the study.

Negative response (i.e., unwilling to use or unable to tolerate \[e.g., experiences Adverse Events during the product trial that will prevent the subjects from continuing to use the JUUL product as judged by the Investigator\]) to any of the JUUL products at Screening.

Has donated plasma within 7 days prior to Day -2 (Check-in).

Has donated blood or blood products (with the exception of plasma as noted above), has had significant blood loss, or received whole blood or a blood product transfusion within 3 months prior to Day -2 (Check-in).

Has taken any multivitamin, fish oil or biotin supplements within 48 hours prior to Check-in (Day -2).

Has consumed any cured meats (e.g., bacon, ham, sausage, corned beef, jerky) or meats cooked at high temperatures (e.g., grilled, fried, smoked or barbecued) within 2 days prior to Check-in (Day -2).

Has consumed any grapefruit (including grapefruit juice) eggplant or cruciferous vegetables (e.g., cauliflower, cabbage, kale, garden cress, bok choy, broccoli, brussels sprouts and similar green leaf vegetables) within 48 hours prior to Check-in (Day -2).

Has participated in a previous clinical study for an investigational drug, device, biologic, or tobacco product within 30 days prior to Day -2 (Check-in).

Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee of any of the study sites.

Is or has a first-degree relative (i.e., parent, sibling, child) who is a current employee, shareholder, or is member of the board of directors of JUUL Labs Inc.

Has previously taken part in, been withdrawn from, or has completed this study.

Has previously been diagnosed with any form of cancer, except for basal cell or squamous epithelial carcinomas of the skin that have been resected at least 1 year prior to Screening.

In the opinion of the Investigator, the subject should not participate in this study.

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

What this study is about

Changes in Biomarkers of Cigarette Smoke Exposure After Switching Either Exclusively or Partly to JUUL ENDS

What this study is about