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:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT05459857
Eligibility Criteria:
Inclusion Criteria:
* Reports smoking an average of at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day for at least 12 months prior to Screening
* Has a positive urine cotinine (\>500 ng/mL) at Screening
* Has an exhaled carbon monoxide \>10 ppm at Screening
* A female subject of childbearing potential must use contraception
* Male subject must use contraception
Exclusion Criteria:
* Has a history or presence of clinically significant disease or condition that, in the opinion of the Investigator, would jeopardise the safety of the subject or impact the validity of the study results.
* Has a positive test for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) at Screening
* Has a fever (\>38.05°C) at Screening or check-in
* Has a history or presence of drug or alcohol abuse within 24 months of Check-in
* Pregnant or lactating females
* Has used any prescription smoking cessation treatments within 3 months prior to Check-in
* Is planning to quit smoking during the study or within the next 3 months
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05459857
Study Brief:
Protocol Section:
NCT05459857