CSD231005 Nicotine Pouch Biomarkers of Exposure

Exclusion Criteria

• •The 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 subject unsuitable to participate in this clinical study.
• •History, presence of, or clinical laboratory test results indicating diabetes. Fasting plasma glucose \> 126 mg/dL (7 mmol/L) is exclusionary. One recheck may be performed for fasting plasma glucose values \> 126 mg/dL but \< 200 mg/dL.
• •Scheduled treatment for asthma currently or within the past 12 consecutive months prior to Screening. As needed treatment, such as inhalers, may be included at the PI's discretion, pending approval from the Medical Monitor.
• •Use of any medications that interfere with the cyclooxygenase pathway (e.g., antiinflammatoryanti-inflammatory drugs such as aspirin and ibuprofen) 14 days prior to CheckIn on Day 2.
• •Use of medications or substances (other than nicotine) known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 halflives of the medication or substances (whichever is longer) prior to CheckIn on Day 2.
• •History or presence of bleeding or clotting disorders.
• •Any history of cancer, except for primary cancers of the skin, such as localized basal cell/squamous cell carcinoma, that have been surgically and/or cryogenically removed.
• •Systolic blood pressure (BP) of \> 160 mmHg or a diastolic BP of \> 95 mmHg, measured after being seated for 5 minutes at Screening and CheckIn on Day 2.
• •Body Mass Index (BMI) \< 18.0 or \>40.0 kg/m2 (weight of ≤ 110 pounds) at Screening.
• •Hemoglobin level \< 12.5 g/dL for females or \<13.0 g/dL for males at Screening.
• •Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study.
• •A positive urine drug screen without evidence of prescribed corresponding concomitant medication(s) at Screening or CheckIn on Day 2.
• •Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBbsAg), or hepatitis C virus (HCV).
• •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 of the ICF.
• •Postpones a decision to quit using tobacco or nicotinecontaining products to participate in this study or has made a previous quit attempt within (≤) 30 days prior to the signing of the ICF.
• •Any daily use of aspirin (≥ 325 mg/day) or anticoagulants (e.g., Clopidogrel \[Plavix®\], Warfarin \[Coumadin®, Jantoven®\]).
• •Individuals ≥ 35 years of age currently using systemic, estrogencontaining contraception or hormone replacement therapy.
• •Whole blood donation within 8 weeks (≤ 56 days) prior to the signing of the ICF.
• •NOTE: Subjects will be advised against scheduling a whole blood donation for at least 7 days following study completion.
• •Plasma donation within (≤) 7 days prior to the ICF. NOTE: Subjects will be advised against scheduling a plasma donation for at least 7 days following study completion.
• •Employed by a tobacco or nicotine company, the study site, or handles tobacco or nicotinecontaining products as part of their job.
• •Participation in another clinical trial within (≤) 30 days prior to the signing of the ICF. The 30day 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.
• •Drinks more than 21 servings of alcoholic beverages per week.
• •Has a positive alcohol result at Screening or CheckIn on Day 2.
• •Determined by the PI to be inappropriate for this study.