| Eligibility |
Inclusion Criteria:
All Subjects
1. Able to read, understand, and willing to sign an Informed Consent Form (ICF) and
complete questionnaires written in English or Spanish.
2. Generally healthy male or female, 26 to 55 years of age, inclusive, at the time of
consent.
3. Body mass index (BMI) within 18.0 to 40.0 kg/m2, inclusive (minimum weight of at least
110 lbs. [50 kg]) at Screening.
4. Agree to abide by the study restrictions and requirements, including use of the
assigned product or to undergo smoking cessation, and agree to in-clinic, overnight
confinement at Visits 1 and 4.
5. Willing to refrain from consuming alcohol within 24 hours prior to Screening and
check-in at Visits 1 and 4.
6. Willing to refrain from consuming cruciferous vegetables and grilled, smoked, fried or
barbequed food, and to avoid being in the presence of the cooking of these foods, and
to refrain from consuming cured sandwich meats, bacon, salami, and sausages, for 48
hours prior to check-in at Visits 1 and 4.
7. Males must be vasectomized, abstinent from heterosexual intercourse (as a lifestyle
choice, not just for the purpose of study participation), or they (or their female
partner of childbearing potential) must use acceptable methods of birth control from
Visit 1 until the end of the study.
8. Females must be willing to use a form of contraception acceptable to the PI from the
time of signing informed consent until the end of the study.
Examples of acceptable means of birth control are, but not limited to:
1. Surgical sterilization (hysterectomy, bilateral tubal ligation/occlusion,
bilateral oophorectomy, bilateral salpingectomy);
2. Established use of oral, implantable, injectable or transdermal methods of
contraception associated with inhibition of ovulation;
3. Physical barrier method (e.g., condom, diaphragm/sponge/cervical cap) with
spermicide;
4. Non-hormone releasing intrauterine devices (IUD) or hormone-releasing IUDs (e.g.,
Mirena or Kyleena);
5. Vasectomized partner;
6. Abstinence from heterosexual intercourse (as a lifestyle choice, not just for the
purpose of study participation); and
7. Post-menopausal and not on hormone replacement therapy.
Cohorts 1 to 7
9. Smokes manufactured combustible, filtered, non-menthol (cohorts 1 and 5) or menthol
(cohorts 2, 3 and 4) cigarettes (either is acceptable for cohorts 6 and 7), 83 mm to
100 mm in length as their primary source of nicotine.
10. Has smoked for at least the five consecutive years prior to Screening. Brief periods
of abstinence due to illness, quit attempt (more than 30 days prior to Screening), or
clinical study participation (more than 30 days prior to Screening) will be allowed at
the discretion of the PI.
11. Smokes an average of at least 10 and a maximum of 30 cigarettes per day (CPD) and
inhales the smoke.
12. Exhaled breath carbon monoxide (eCO) level is = 7 ppm and = 100 ppm at Screening.
13. Positive urine cotinine test at Screening.
14. If assigned to cohort 1, 2, 3, 4 or 5, willing to use only the study product (HTP)
provided to them during the study.
15. If assigned to cohort 6, willing to continue to smoke factory-manufactured cigarettes.
16. For cohort 7 only, willing to refrain from smoking or using any form of tobacco or
nicotine-containing product (other than nicotine replacement therapy (NRT) where
agreed as part of their smoking cessation strategy).
17. Agree not to allow any other person to use any product provided to them for use during
this study, nor to dispose of any product provided to them for use during this study
with the exception of the disposal of used HTP sticks or used NRT.
Cohort 8
18. Never have smoked (<100 cigarettes in their life), not have smoked or used any
nicotine or tobacco product within 30 days prior to Screening, and will continue not
to smoke or use any form of tobacco or nicotine-containing product (including HTPs)
for the duration of the study.
19. Lives in a non-smoking household and is not employed in a role which regularly exposes
them to tobacco smoke (e.g., bar worker).
20. Exhaled breath carbon monoxide (eCO) level is < 7 ppm at Screening.
21. Negative urine cotinine test at Screening.
Exclusion Criteria:
All Subjects
1. Presence of clinically significant uncontrolled cardiovascular, pulmonary, renal,
hepatic, endocrine, gastrointestinal, psychiatric, hematological, neurological
disease(s), 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 (history
of gestational diabetes which is no longer present nor indicated by clinical
laboratory test results is acceptable).
3. 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.
4. Subjects who have had an acute illness (e.g., upper respiratory tract infection)
requiring treatment within 4 weeks prior to Visit 1 (subjects who had viral infections
that resolved = 2 weeks prior to Visit 1 will be admissible).
5. Subjects who have received any medications or substances (other than nicotine) which:
1. interfere with the cyclooxygenase pathway (e.g., anti-inflammatory drugs
including aspirin and ibuprofen) within 14 days prior to Visit 1
2. are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes
within 14 days or 5 half-lives of the drug (whichever is longer) prior to Visit 1
6. History or presence of bleeding or clotting disorders.
7. 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.
8. Systolic blood pressure of > 160 mmHg or a diastolic blood pressure of > 95 mmHg,
measured after being seated for five minutes.
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/saliva drug screen without evidence of prescribed corresponding
concomitant medication(s) at the Screening Visit or Visit 1, 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 the PI or
appropriately qualified designee.
11. Positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen
(HBsAg), or hepatitis C virus (HCV).
12. Individuals = 35 years of age currently using systemic, estrogen-containing
contraception or hormone replacement therapy.
13. Participation in another clinical trial within (=) 30 days prior to 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 informed consent in the current
study.
14. Subjects who have donated:
1. =400 mL of blood within 30 days prior to screening, or during the period from
signing informed consent to check-in at Visit 1
2. plasma in the 7 days prior to screening, or during the period from signing
informed consent to the end of study (Visit 4)
15. Employed by a tobacco or nicotine company, the study site, or handles tobacco- or
nicotine-containing products as part of their job.
16. Has a significant history of alcoholism or drug abuse within 24 months prior to
Screening, as determined by the PI, or has a positive urine/breath alcohol test at
Screening or Visit 1.
17. Determined by the PI to be inappropriate for this study.
Cohorts 1 to 6
18. 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 of the ICF.
19. 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 the
signing the ICF.
Cohorts 1 to 7
20. Currently uses any nicotine or tobacco product, other than CC, more than one day per
week.
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