| Eligibility |
Inclusion Criteria:
1. Able to read, understand, and willing to sign an informed consent form (ICF) and
complete questionnaires written in English.
2. Generally healthy males or females, 21 to 60 years of age, inclusive, at the time of
consent.
3. Smoke manufactured combustible, filtered, non-menthol or menthol cigarettes, 83 mm to
100 mm in length as primary source of tobacco.
4. Smokers who self-report use of a smokeless tobacco product (loose or pouch) prior to
screening may also be enrolled.
5. Smokes an average of at least 10 cigarettes per day (CPD) and inhale the smoke, for at
least 6 months prior to screening. Brief periods of abstinence due to illness, quit
attempt (prior to 30 days of screening), or clinical study participation (prior to 30
days of screening) will be allowed at the discretion of an investigator.
6. Agrees to smoke the same Usual Brand (UB) cigarette throughout the study period. The
UB cigarette is defined as the reported cigarette brand and style currently smoked
most frequently by the subject. If a subject reports use of a different UB cigarette
at check in, that subject may continue provided they use that same UB cigarette
throughout the study.
7. Expired breath carbon monoxide (ECO) level is = 10 ppm and = 100 ppm at screening.
8. Positive urine cotinine test at screening.
9. Willing to use the UB cigarette and nicotine pouch or lozenge IPs during the study
period.
10. Willing to abstain from tobacco and nicotine use for at least 12 hours prior to start
of each of six test sessions.
11. If female and of non-childbearing potential, must meet one of the following criteria:
1. Surgically sterile (i.e., has undergone complete hysterectomy, bilateral
oophorectomy, or tubal ligation/occlusion); or
2. In a menopausal state (at least 1 year without menses), as confirmed by follicle
stimulating hormone (FSH) levels (=40 mIU/mL).
12. If female and of childbearing potential, must agree to use one of the accepted
contraceptive regimens from at least 30 days prior to the first administration of the
IP during the study, and for at least 30 days after the last dose of the IP. An
acceptable method of contraception includes one of the following:
1. Abstinence from heterosexual intercourse;
2. Hormonal contraceptives (birth control pills, injectable/implant/insertable
hormonal birth control products, transdermal patch);
3. Intrauterine device (with or without hormones); or
4. Use of a double barrier method (e.g., condom and spermicide) during the study and
for at least 30 days after the last dose of the study medication.
13. Agrees to an in-clinic confinement of 7 days (6 nights).
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
an investigator, makes the study subject unsuitable to participate in this clinical
study.
2. History, presence of, or clinical laboratory test results indicating diabetes.
3. 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 an investigator's discretion pending approval from the Medical Monitor.
4. History or presence of bleeding or clotting disorders.
5. 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.
6. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg,
measured after being seated for five minutes at screening and at check-in Day 1.
7. Weight of = 110 pounds.
8. Hemoglobin level is < 12.5 g/dL for females or <13.0 g/dL for males at screening.
9. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to
become pregnant during the course of the study.
10. Positive urine drug screen without evidence of a prescription or urine alcohol test at
Day 1 (check-in), with the exception of for tetrahydrocannabinol (THC). If positive
for THC, a cannabis intoxication evaluation will be performed at check-in, and
inclusion will be at the discretion of an investigator.
11. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C virus (HCV).
12. Self reports use of the study IP (nicotine pouches or lozenges) currently or in the
past.
13. Recreationally uses vapor products (e.g., e-cigarettes, tank systems) more than one
day per week, for the past 6 months prior to screening.
14. Current, regular user (i.e., > 5 times per month) of any tobacco products other than
combustible cigarettes or smokeless tobacco within the last 6 months prior to
screening.
15. 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.
16. Postpones a decision to quit using tobacco- or nicotine-containing products in order
to participate in this study or self-reports a previous attempt within (=) 30 days
prior to the signing the informed consent.
17. Any use of aspirin (= 325 mg/day) or anticoagulants within (=) 30 days prior to the
signing of informed consent.
18. Individuals = 35 years of age currently using systemic, estrogen-containing
contraception or hormone replacement therapy.
19. Whole blood donation within 8 weeks (= 56 days) prior to the signing of informed
consent and between screening and check-in Day 1.
20. Plasma donation within (=) 7 days prior to the signing of informed consent and between
screening and check-in 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. 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 of informed consent
in the current study.
23. Drinks more than 21 servings of alcoholic beverages per week or has a positive alcohol
result at screening or check-in Day 1.
24. Determined by an investigator to be inappropriate for this study.
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