Study subjects
disease or disorder, allergic, blood loss, exhaled carbon monoxide, acute illness, amenorrhea, CPD, blood or blood products
BLOOD LOSS, UPPER RESPIRATORY TRACT INFECTION, VIRAL INFECTION
In total, 51 subjects were screened for participation in this study; 27 subjects either failed screening or were not needed for study participation (i.e., they were study reserves but were not required to take part in the study). Of the 24 enrolled subjects, 23 completed the study; one subject withdrew from the study for personal reasons.Inclusion criteria were that subjects were healthy adults aged 21–65 years inclusive at screening; self-reported smoking at least 10 manufactured combustible (menthol or non-menthol) cigarettes per day (CPD) for at least 12 months prior to screening; had a urine cotinine ≥ 500 ng/mL at screening; had an exhaled carbon monoxide (eCO) level > 10 parts per million (ppm) at screening; if female and of childbearing potential were using at least one approved form of contraception; if female and of non-childbearing potential had undergone a sterilisation procedure at least 6 months prior to check-in or was postmenopausal with amenorrhea (verified by measuring follicle-stimulating hormone (FSH) levels) for at least 1 year prior to check-in; if a non-vasectomised male agreed to use a condom with spermicide or abstain from intercourse for the duration of the study and extending up to 90 days post-study; if male agreed not to donate sperm for duration of the study and extending up to 90 days post-study; was willing comply with the requirements of the study, including a willingness to use the study HTPs; and provided voluntary consent to participate in this study, which was documented by signing of the signed informed consent form.Subjects were not allowed to enter the study if any exclusion criteria were met. The main exclusion criteria were a history or presence of clinically significant disease or disorder that, in the opinion of the Investigator, would have jeopardised the safety of the subject or impacted the validity of the study results; had a clinically significant abnormal finding on the physical examination, medical history, vital signs, electrocardiogram, or clinical laboratory results; had an acute illness (e.g., upper respiratory tract infection, viral infection) requiring treatment within 14 days prior to Check-in; systolic blood pressure (BP) < 90 mmHg or > 150 mmHg, diastolic BP < 40 mmHg or > 95 mmHg, or heart rate (HR) < 40 bpm or > 99 bpm at screening; estimated creatinine clearance (using the Cockcroft Gault equation) < 70 ml/min at screening; used medications known to interact with cytochrome P450 2A6 within 3 months prior to check in and throughout the study; used inhalers to treat any medical condition within 3 months prior to check in and throughout the study; used prescription or over-the-counter bronchodilator medication (e.g., inhaled or oral β-agonists) for treatment of any illness within 12 months prior to check in and throughout the study; was allergic to or could not tolerate menthol flavouring agents; had used any prescription smoking cessation treatments, including, but not limited to, varenicline (Chantix®) or bupropion (Zyban®) within 3 months prior to check in; was planning to quit smoking during the study or within the next 3 months or was postponing a quit attempt in order to participate in the study; or had donated blood or blood products (including plasma), had significant blood loss, or received whole blood or a blood product transfusion within 90 days prior to check in.