| Eligibility |
Inclusion Criteria:
1. Voluntary consent to participate in this study documented on the signed ICF
2. Smoking history (self-reported at screening) of an average of at least 10 but no more
than 30 factory-manufactured combustible cigarettes (either menthol or non-menthol)
daily for at least 12 months prior to screening. Brief periods (ie, up to 7
consecutive days) of non-smoking during the 3 months prior to screening (eg, due to
illness or participation in a study where smoking was prohibited) will be permitted
3. Positive urine cotinine (= 500 ng/mL) at screening
4. Female subjects who are heterosexually active and of childbearing potential (eg,
neither surgically sterile at least 6 months prior to check-in nor postmenopausal with
amenorrhea for at least 12 months prior to check-in with follicle-stimulating hormone
[FSH] levels consistent with postmenopausal status) must have been using one of the
following forms of contraception for the time period indicated and agree to continue
using it through completion of the study:
- Hormonal (eg, oral, vaginal ring, transdermal patch, implant, injection)
consistently for at least 3 months prior to check-in, double barrier (ie, condom
with spermicide or diaphragm with spermicide) consistently for at least 4 weeks
prior to check-in, an intrauterine device for at least 4 months prior to check-in
- Exclusive partner who has been vasectomized for at least 6 months (inclusive)
prior to check-in
Female subjects of childbearing potential who are not currently engaging in
heterosexual intercourse must agree to use one of the above methods of birth control
through completion of study, in the event that they have heterosexual intercourse
during the course of the study.
5. Female subjects who are of nonchildbearing potential must have undergone one of the
following sterilization procedures at least 6 months prior to check-in:
Hysteroscopic sterilization (including Essure® or similar nonsurgical sterilization
procedures); bilateral tubal ligation or bilateral salpingectomy; hysterectomy;
bilateral oophorectomy
Or be postmenopausal with amenorrhea for at least 12 months prior to check-in and have
FSH levels consistent with postmenopausal status
6. Willing to comply with the requirements of the study
7. Willing to use all 3 on!® NP after the Product Trial at check-in
8. Willing and able to abstain from cigarettes from Day 1 through the end of the study
(EOS)
9. Healthy adult males and females, 21 to 65 years of age, inclusive at screening, with
subjects aged 46 to 65 years being fully vaccinated for COVID-19 (SARS-CoV-2) at least
14 days before the screening visit.
Exclusion Criteria:
1. Use of any type of tobacco- or nicotine-containing products other than manufactured
cigarettes (eg, e-vapor products, roll-your-own cigarettes, bidis, snuff, nicotine
inhaler, pipe, cigar, chewing tobacco, nicotine patch, nicotine spray, nicotine
lozenge, or nicotine gum) in the 7 days prior to check-in
2. Self-reported puffers (ie, adult smokers who draw smoke from the cigarette into the
mouth and throat but do not inhale)
3. Planning to quit smoking in the next 30 days (from screening visit)
4. History or presence of clinically significant gastrointestinal, renal, hepatic,
neurologic, hematologic, endocrine, oncologic, urologic, existing respiratory
diseases, immunologic, psychiatric, lymphatic, or cardiovascular disease, or any other
condition that, in the opinion of the investigator, would jeopardize the safety of the
subject or impact the validity of the study results
5. Clinically significant abnormal findings on the vital signs, physical examination,
medical history, electrocardiogram (ECG), or clinical laboratory results, in the
opinion of the investigator
6. Positive test for human immunodeficiency virus, hepatitis B surface antigen, or
hepatitis C virus at screening
7. History or presence of any type of malignant tumors
8. Current evidence or any history of congestive heart failure
9. Diabetes mellitus (fasting glucose =126 mg/L [7 mmol/L]) that is not controlled by
diet/exercise alone, in the opinion of the investigator
10. An acute illness (eg, upper respiratory infection, viral infection) requiring
treatment with prescribed medicines within 2 weeks prior to check-in
11. Dentition that prevents subjects from using on!® NP products
12. Allergic to or cannot tolerate mint flavoring agents or phenylalanine
13. Any planned surgery from the time of screening through EOS
14. History of drug or alcohol abuse within 24 months prior to check-in
15. Fever (ie, body temperature >100.5°F) at screening or check-in. One recheck may be
performed at the investigator's discretion
16. Body mass index greater than 40.0 kg/m2 or less than 18.0 kg/m2 at screening
17. Systolic blood pressure >150 mmHg and/or diastolic blood pressure > 90 mmHg at
screening or check-in, measured after being seated for at least 5 minutes. One recheck
may be performed at the investigator's discretion
18. Estimated creatinine clearance (by Cockcroft-Gault equation) < 80 mL/minute at
screening
19. Serum alanine aminotransferase =1.5 times the upper limit of normal and/or aspartate
aminotransferase =1.5 times the upper limit of normal at screening
20. Positive screen for alcohol (breath) or any of the following drugs of abuse (urine),
regardless of the reason of use: amphetamines, methamphetamines, opiates,
cannabinoids, or cocaine at screening or check-in
21. Female subjects who are pregnant (positive serum pregnancy test at screening or urine
pregnancy test at check-in), lactating, or intend to become pregnant from screening
through EOS
22. Use of prescription or over-the-counter bronchodilator medication (eg, inhaled or oral
ß-agonists) within 12 months prior to check-in
23. Use of medications or foods known or are suspected to interact with cytochrome P450
2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital,
buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone,
fenofibrate, isoniazid, grapefruit, ketoconazole, letrozole, methimazole, methoxsalen,
metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital,
pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital,
selegiline, sulconazole, tioconazole, tranylcypromine) within 14 days or 5 half-lives
of the drug, whichever is longer, prior to check-in or during the study
24. Use of antibiotic treatment within 2 weeks prior to check-in
25. Plasma donation within 7 days prior to check-in
26. Donation of blood or blood products (with the exception of plasma as noted above), had
significant blood loss, or received whole blood or a blood product transfusion within
56 days prior to check-in
27. Participation in a previous clinical study for an investigational drug, device,
biologic, or a tobacco product within 30 days prior to check-in
28. Participation in 2 or more Altria Client Services (ALCS) studies within the past
12-month period prior to check-in
29. Subject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a
current or former employee of the tobacco industry or a named party or class
representative in litigation with any tobacco company
30. Subject or a first-degree relative (ie, parent, sibling, child, spouse/partner) is a
current employee of the study site
31. Positive result for coronavirus disease (COVID)-19 (SARS-CoV-2) test at screening or
check-in
32. One or more "yes" answers to any of the questions on the COVID-19 (SARS-CoV-2)
screening questionnaire (provided by the study site) at screening or check-in.
33. Have been diagnosed with major depressive disorder or have a history of suicide
attempt.
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