Eligibility Details:
Inclusion Criteria:
- Able to read, understand, and willing to sign an informed consent form (ICF) and
complete questionnaires written in English;
- Generally healthy male or female, 21 to 60 years of age, inclusive, at the time of
signing informed consent;
- Positive urine cotinine test at the Screening Visit and Day 1;
- Females must be willing to use a form of contraception acceptable to the Principal
Investigator (PI) from the time of signing the ICF until study discharge;
- Subjects' primary tobacco product must be a moist snuff product. Dual use of other
forms of tobacco- and/or nicotine-containing products will be allowed but not more
frequently than four days per week;
- Self-reports currently using at least one can of their non-pouched usual brand (UB)
moist snuff per week for at least 3 months prior to Enrollment;
- Agrees to exclusively use the IP and not use any other tobacco- or nicotine-containing
product during the course of the study;
- Able to safely perform the required study procedures, as determined by the PI.
Exclusion Criteria:
- Presence of clinically significant or unstable/uncontrolled acute or chronic medical
conditions at the time of signing the ICF, as determined by the PI, that would
preclude a subject from participating safely in the study (e.g., uncontrolled
hypertension, cardiac disease, neurological disease, psychiatric disorders) based on
safety assessments such as clinical laboratory tests, pregnancy tests, medical
history, and physical/oral examinations;
- History, presence of, or clinical laboratory test results indicating diabetes;
- Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95mmHg,
measured after being seated for 5 minutes;
- Hemoglobin level < 12.5 g/dL for females and < 13.0 g/dL for males at the Screening
Visit;
- Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C virus (HCV);
- 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;
- Use of any medication or substance that aids in smoking cessation, including but not
limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch),
varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or lobelia extract within 30
days prior to signing the ICF;
- History or presence of bleeding or clotting disorders;
- Any use of anticoagulants or aspirin (>325mg/day);
- Whole blood donation within 8 weeks (≤ 56 days) prior to the signing the ICF;
- Plasma donation within (≤) 7 days of signing the ICF;
- 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);
- Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to
become pregnant during the course of the study;
- Individuals ≥ 35 years of age currently using systemic, estrogen-containing
contraception or hormone replacement therapy;
- A positive urine drug screen without evidence of prescribed corresponding concomitant
medication(s) at the Screening Visit or Day 1;
- Postponing 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
signing the ICF;
- Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol
test result at the Screening Visit or Day 1;
- Employed by a tobacco- or other nicotine-product manufacturing company, or the study
site;
- Determined by the PI to be inappropriate for the study.
common.study.methods.has-drugs-no
common.study.methods.is-healthy-no
