CSD201202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12

Exclusion Criteria

• •1. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal, hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological disease, or any other concurrent disease or medical condition that, in the opinion of the PI, makes the study subject unsuitable to participate in this clinical study.
• •2. History, presence of, or clinical laboratory test results indicating diabetes.
• •3. Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95mmHg, measured after being seated for five minutes at Screening and at check-in Day 1.
• •4. Weight of ≤ 110 pounds.
• •5. Hemoglobin level is \< 12.5 for females or \<13.0 for males g/dL at Screening.
• •6. Scheduled treatment for asthma currently or within the past consecutive 12 months prior to the Screening Visit. As-needed treatment, such as inhalers, may be included at the PI's discretion pending approval from the Medical Monitor.
• •7. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV).
• •8. Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that has been surgically and/or cryogenically removed.
• •9. Must not be a current regular user (i.e., \> 5 times per month) of any tobacco products other than CCs or ENDS within the last 6 months prior to screening.
• •10. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (NRT) (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within (≤) 30 days prior to the signing of informed consent.
• •11. History or presence of bleeding or clotting disorders.
• •12. Any use of anticoagulants or daily use of aspirin (≥ 325 mg).
• •13. Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of informed consent and between Screening and check-in Day 1.
• •14. Plasma donation within (≤) 7 days prior to the signing of informed consent and between Screening and check-in Day 1.
• •15. Participation in another clinical trial within (≤) 30 days prior to the signing of informed consent. The 30-day window for each subject will be derived from the date of the last study event in the previous study to the time of signing the ICF in the current study.
• •16. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
• •17. Individuals ≥ 35 years of age currently using systemic, estrogen-containing contraception or hormone replacement therapy.
• •18. A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or Day 1.
• •19. Postpones a decision to quit using tobacco- or nicotine-containing products in order to participate in this study or a previous quit attempt within (≤) 30 days prior to the signing of the ICF.
• •20. Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol result at Screening or Day 1.
• •21. Employed by a tobacco or nicotine company, the study site, or handles tobacco- or nicotine-containing products as part of their job.
• •22. Determined by the PI to be inappropriate for this study.