Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:19 AM
Ignite Modification Date:
2025-12-25 @ 3:19 AM
NCT ID:
NCT06476405
Eligibility Criteria:
Inclusion Criteria:
Individuals must meet all of the following inclusion criteria to be eligible for participation in the study:
1. Provides voluntary consent to participate in this study documented on the signed ICF.
2. Adult, male or female, 22 to 65 years of age, inclusive, at the Screening visit.
3. Self-reports at the Screening Visit smoking at least 5 non-menthol or menthol combustible cigarettes per day for at least 12 months prior to Screening. \[Prior to screening, brief periods (i.e., up to 7 consecutive days) of non-smoking within 90 days before Check-in (e.g., due to illness or participation in a clinical study where tobacco use was prohibited) will not be exclusionary at the discretion of the Investigator (other non-daily tobacco use, except for heated tobacco use, within 30 days prior to screening are not exclusionary)\].
4. Able to communicate effectively with the study personnel and willing to comply with the requirements of the study.
5. Subjects must be generally healthy, and without clinically significant abnormalities as assessed by the Investigator based on the review of medical and surgical history, physical examination, vital signs measurement, 12-lead ECG, and laboratory evaluations conducted at Screening (refer to Table 1).
6. Screening blood pressure ≤ 150/90 mmHg measured after being seated for at least 10 minutes. Two rechecks may be performed at the Investigator's discretion.
7. Urine cotinine ≥ 200 ng/mL at Screening.
8. Exhaled carbon monoxide ≥ 10 ppm at Screening.
9. Female subjects who are sexually active and of childbearing potential (e.g., not surgically sterile at least 6 months prior to Screen nor postmenopausal with amenorrhea for at least 1 year prior to screen and FSH levels consistent with postmenopausal status) must not be lactating and must have been using 1 of the following forms of contraception from 3 months before study product administration through 30 days after the final administration of study product:
* Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to Check-in, when used in combination with male condoms with spermicide (use of NuvaRing® is at the Investigator's discretion)
* Double barrier (e.g., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to Check-in
* Intrauterine device or system (utilize Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to Check-in
* Exclusive partner who is clinically sterile (i.e., documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to Check-in Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in line with the preferred and usual lifestyle of the subject.
* 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.
10. Female subjects who are of non-childbearing potential must have undergone 1 of the following sterilization procedures at least 6 months prior to Check-in:
* Hysteroscopic sterilization with documentation of success with hysterosalpingogram
* Bilateral tubal ligation or bilateral salpingectomy
* Hysterectomy
* Bilateral oophorectomy
* Essure® or, be postmenopausal with amenorrhea for at least 1 year prior to Screen and confirmed by FSH levels consistent with postmenopausal status.
Exclusion Criteria:
Individuals who meet any of the following exclusion criteria will not be enrolled in the study:
1. History or presence of any type of malignant tumor or clinically significant or unstable/uncontrolled acute or chronic medical conditions at Screening, as determined by the Investigator, that would impact the safety of the participant or the validity of the study results (e.g., hypertension, diabetes, asthma, or other lung disease, cardiac disease, neurological disease, psychiatric disorders).
2. Current evidence or any history of congestive heart failure.
3. Any other condition or prior therapy that, in the Investigator's opinion, would make the subject unsuitable for the study, or unable or unwilling to comply with the study procedures.
4. Clinically significant abnormal vital sign, physical examination (including oral cavity an oropharynx), ECG, medical history, or clinical laboratory findings, in the opinion of the Investigator.
5. Positive test for HIV-1 or HIV-2; or HbsAg or HCV consistent with current infection at Screening.
6. Diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the Investigator. Fasting plasma glucose \> 126 mg/dL \[7 mmol/L\] is exclusionary. One recheck may be performed for fasting plasma glucose values \> 126 mg/dL but \< 200 mg/dL.
7. An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to each study visit.
8. Self-reported puffers (i.e., smokers who draw smoke from the combustible cigarette into the mouth and throat but do not inhale).
9. Postponing a decision to quit smoking (defined as planning a quit attempt within 30 days of the Screening Visit) to participate in this study.
10. Employees and first-degree relatives (i.e., parent, sibling, child, spouse) of the Sponsor and Sponsor representatives, a tobacco company, the study site, or the environmental test chamber vendor.
11. Females who have a positive pregnancy test (at Screen and every visit), are pregnant, breastfeeding, or intend to become pregnant during the study.
12. History of claustrophobia.
13. History of alcohol abuse, illicit drug use, physical dependence to any opioid, or any history of drug abuse within 24 months prior to Screen
14. Positive screen for alcohol (breath or urine) or any of the following drugs of abuse (urine), regardless of the reason of use: amphetamines, methamphetamines, opiates, or cocaine at Screening.
15. Fever (i.e., body temperature \> 100.5 F) at Screening or every CTS visit; 1 recheck may be performed at the Investigator's discretion.
16. Body mass index \> 40.0 kg/m2 or \< 18.0 kg/m2 at Screening (1).
17. Estimated glomerular filtration rate \< 80 mL/minute using the CKD-EPI (2) formula at Screening.
18. Use of prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral ß agonists) for treatment of any illness within 12 months prior to Screen.
19. Currently participating in another clinical study; or participation in \> 2 ALCS-sponsored studies within the past 12-month period prior to Screen.
20. Negative response (i.e., unwilling to use or unable to tolerate \[e.g., experiences AEs during the Product Trial that will prevent the subject from continuing to use the product as judged by the Investigator\]) to the product during the Product Trial visit.
21. Regularly exposed to solvent fumes or gasoline (e.g., painter, gas-station mini mart employee).
22. Unable to communicate or unwilling to cooperate with the clinical staff in the opinion of the Investigator.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
22 Years
Maximum Age:
65 Years
Study:
NCT06476405
Study Brief:
Protocol Section:
NCT06476405