| Eligibility |
Inclusion Criteria:
- Subject candidates must satisfy the following criteria before being enrolled in the
study:
1. provide voluntary consent to participate, as documented by the signed
institutional review board (IRB)-approved informed consent form (ICF) for the
study;
2. be between the ages of 21 and 65 years, inclusive, at the time of screening
(Visit 1);
3. be positive for tobacco use by urine cotinine measurement (= 500 ng/mL) at Visit
1 (screening);
4. have used nicotine-containing EVPs for the 3 months before Visit 1 (screening)
and use of nicotine-containing EVPs ("some days" or "every day") for the past 30
days and at least 4 out of the past 7 days before Visit 1 (screening) and at
check-in for Visit 2;
5. have negative alcohol, amphetamines, opiates, cannabinoids, phencyclidine, and
cocaine urine drug screening results (exhaled breath test for alcohol is also
acceptable) at Visit 1 (screening) and at check-in for Visit 2;
6. if female (all females), have a negative serum pregnancy test at Visit 1
(screening) and have a negative urine pregnancy test at check-in for Visit 2;
7. if female and heterosexually active and of childbearing potential (e.g., not
surgically sterile [i.e., bilateral tubal ligation, hysterectomy, or bilateral
oophorectomy] at least 6 months before Visit 1 [screening] or at least 2 years
naturally postmenopausal [follicle-stimulating hormone =40 IU/L at Visit 1
(screening)]), must be using one of the following forms of contraception and
agree to continue using it through at least 30 days after the last study product
use (if early terminated) or completion of the study:
- hormonal (e.g., oral, transdermal patch, implant, or injection) consistently
for at least 3 months before Visit 1 (screening);
- double barrier (i.e., condom with spermicide or diaphragm with spermicide)
consistently for at least 30 days before Visit 1 (screening);
- intrauterine device for at least 3 months before Visit 1 (screening);
- Essure® or similar nonsurgical sterilization procedure at least 3 months
before Visit 1 (screening); or
- partner who has been vasectomized for at least 6 months (inclusive) before
Visit 1 (screening);
8. if male and heterosexually active and capable of fathering a child (e.g., not
vasectomized at least 6 months before Visit 1 [screening]), must be using a
double barrier (i.e., condom with spermicide or diaphragm with spermicide) method
of contraception from check-in at Visit 2 until at least 90 days after the last
study product use (if early terminated) or completion of the study;
9. not plan to quit e-vapor use in the next 30 days;
10. be willing to use all assigned EVPs during the study; and
11. be willing and able to comply with the requirements of the study.
Exclusion Criteria:
- Subjects may be excluded from the study if the subject meets any of the criteria
listed below at Visit 1 (screening) and Visit 2 or at any time during the study as
appropriate. Exceptions may be permitted at the discretion of the investigator in
consultation with the Sponsor, providing there would be no additional risk involved
for the subject. Any exceptions will be documented.
1. have a history or presence of clinically significant gastrointestinal, renal,
hepatic, neurologic, hematologic, endocrine, oncologic, urologic, diabetes,
existing respiratory diseases (especially bronchospastic diseases and asthma),
immunologic, psychiatric, cardiovascular disease, or any other condition(s) that,
in the opinion of the investigator, would jeopardize the safety of the subject or
impact the validity of the study results (Note: Chronic medical conditions
controlled and on stable medications [over the past 3 months] may not be
exclusionary per investigator discretion);
2. have current evidence or any history of congestive heart failure;
3. have clinically significant abnormal findings on physical examination, vital
signs, ECG, clinical laboratory results, or medical history, in the opinion of
the investigator;
4. have systolic blood pressure >140 mm Hg or diastolic blood pressure >90 mm Hg at
Visit 1 (screening) or at check-in for Visit 2;
5. have estimated creatinine clearance (by Cockcroft-Gault equation) <80 mL/minute;
6. have liver enzymes (aspartate aminotransferase and alanine aminotransferase) =1.5
times the upper limit of normal at Visit 1 (screening);
7. have an acute illness (e.g., upper respiratory infection or viral infection)
requiring treatment within 2 weeks before check-in at Visit 2;
8. have fever (>100.5°F) at Visit 1 (screening) or at check-in for Visit 2;
9. have body mass index (BMI) greater than 40.0 kg/m2 or less than 18.0 kg/m2 at
Visit 1 (screening);
10. have positive test for human immunodeficiency virus (HIV), hepatitis B surface
antigen (HBsAg), or hepatitis C virus (HCV) at Visit 1 (screening);
11. have used prescription or over-the-counter bronchodilator medication (e.g.,
inhaled or oral ß-agonists) within 12 months of Visit 1 (screening) and Visit 2;
12. have diabetes mellitus that is not controlled by diet/exercise alone, in the
opinion of the investigator;
13. have used prescription antidiabetic medication or insulin therapy within 12
months of Visit 1 (screening) and Visit 2;
14. have used medication for depression or asthma within 12 months of Visit 1
(screening) and Visit 2;
15. have a history of drug or alcohol abuse within 12 months of Visit 1 (screening)
and Visit 2;
16. have had allergic or other known adverse reactions to menthol, propylene glycol,
or glycerol;
17. if female, be pregnant, nursing, or planning to become pregnant during the study;
18. have participated in a clinical study for an investigational drug, medical
device, biologic, or for a tobacco product within 30 days before Visit 1
(screening) and Visit 2;
19. be a current or former employee of the tobacco industry or a first-degree
relative (e.g., parent, spouse, sibling, child) of a current or former employee
of the tobacco industry or a named party or class representative in litigation
with any tobacco company;
20. have been involved in the development of the study design/conduct or be a
first-degree relative (e.g., parent, spouse, sibling, child) of someone involved
in the development of the study design/conduct;
21. be a current employee or personnel involved with the study at the site; or
22. have participated in two or more ALCS studies within the past 12-month period
before Visit 1 (screening) and check in at Visit 2.
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