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 @ 2:19 PM
Ignite Modification Date:
2025-12-24 @ 2:19 PM
NCT ID:
NCT05317195
Eligibility Criteria:
Main Inclusion Criteria:
* Subject has smoked continuously for at least the last 3 years prior to the Screening visit.
* Subject has smoked ≥ 10 commercially available cigarettes per day for 4 weeks prior to Screening Visit and Admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥ 500 ng/mL).
* Subject does not plan to quit using tobacco and/or nicotine products within the next 3 months.
* Smoking, healthy subject as judged by the Investigator or designee based on available assessments from the Screening period.
Main Exclusion Criteria:
* As per the Investigator's judgment, the subject cannot participate in the study for any reason other than medical.
* Subject is legally incompetent, or physically or mentally incapable of giving consent.
* Subject has a clinically relevant disease that requires medication, which as per the judgment of the Investigator would jeopardize the safety of the subject.
* Subject has donated or received whole blood or blood products within 30 days prior to Screening Visit.
* Subject has a BMI \< 18.5 kg/m2 or \> 32.0 kg/m2 (Europe) or \> 35.0 kg/m2 (USA).
* For women only: subject is pregnant (does not have negative pregnancy test at Screening Visit and at Admission) or is breastfeeding.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
65 Years
Study:
NCT05317195
Study Brief:
Protocol Section:
NCT05317195