CSD190101: A Study to Assess Nicotine Pharmacokinetic Parameters After Use of Two Smokeless Tobacco Products

Exclusion Criteria

• •1. Presence of clinically significant uncontrolled cardiovascular, chronic 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. Hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening Visit;
• •4. History or presence of bleeding or clotting disorders;
• •5. Daily use of aspirin (\> 325mg/day) or anticoagulants;
• •6. Whole blood donation within 8 weeks (≤ 56 days) prior to the signing the ICF;
• •7. Plasma donation within (≤) 7 days of signing the ICF;
• •8. Systolic blood pressure of \> 160 mmHg or a diastolic blood pressure of \> 95 mmHg, measured after being seated for 5 minutes;
• •9. Weight of ≤ 110 pounds;
• •10. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV);
• •11. Any history of cancer, except for primary cancers of skin such as localized basal cell/squamous cell carcinoma that have been surgically and/or cryogenically removed;
• •12. Use of any medication or substance that aids in smoking cessation, including but not limited to any NRT (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30 days prior to signing the ICF;
• •13. Participation in another clinical trial within (≤) 30 days of signing the ICF (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);
• •14. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the study;
• •15. A positive urine drug screen without evidence of prescribed corresponding acceptable concomitant medication(s) at the Screening Visit or at check-in on Day 1;
• •16. Postponing a decision to quit using tobacco- or nicotine-containing products to participate in this study or a previous quit attempt within (≤) 30 days prior to signing the ICF;
• •17. Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol breathalyzer result at the Screening Visit and check-in on Day 1;
• •18. Employed by a tobacco- or other nicotine-product manufacturing company, or the study site, or handles tobacco- or nicotine-containing products as part of their job;
• •19. Presence of gum bleeding and/or abscess, open mouth sores or oral ulcers at Screening, Check-in, or prior to Day 5 product use (just prior to switching IP);
• •20. Full dentures or braces (with the exception of night guard/retainer, and dental implants which may be allowed; if subjects is missing all lower teeth and does not use dentures will also be allowed);
• •21. Determined by the PI to be inappropriate for the study.