Biomarkers of toxicant exposure, biomarkers of potential harm and physiological measures in subjects who smoke, use Vype vaping products, have quit smoking or have never smoked Not Applicable
Conditions
Interventions
This study does not involve the testing of any investigational medical products. The study involves collection of blood and urine samples to analyse ‘health effect indicators’ in four different popula
Sponsors
British American Tobacco (United Kingdom)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: All Subjects: 1. Subjects will be: 1.1. Males or females 1.2. 19 to 55 years of age, inclusive, demonstrated by appropriate proof of identification 2. Subjects will have a: 2.1. Body mass index (BMI) of 18.5 to 30.0 kg/m², inclusive 2.2. Body weight exceeding 52 kg (males) or 45 kg (females) 3. Subjects will be in good health, as judged by the PI or the appropriately qualified designee based on: 3.1. Medical history (confirmed by volunteer) 3.2. Physical examination 3.3. Vital signs assessment 3.4. 12-lead ECG 3.5. Clinical laboratory evaluations 3.6. Lung function tests/spirometry at screening 4. Subjects will have given their written informed consent to participate in the study and will have agreed to abide by the study restrictions 5. Subjects must demonstrate the ability to comprehend the informed consent form (ICF), be able to communicate well with the PI or the appropriately qualified designee, understand and comply with the requirements of the study, and be judged suitable for the study in the opinion of the PI or the appropriately qualified designee 6. Subjects will refrain from consuming alcohol within 24 hours prior to Screening 7. Subjects will refrain from consuming cruciferous vegetables, and grilled, fried or barbequed food, and avoid being in the presence of the cooking of cruciferous vegetables, and grilled, fried or barbequed food for 48 hours prior to Screening Additional criteria for Arm A subjects only: 8. Subjects will be regular (daily) users of the Vype ePen 3 and/or Vype ePod vaping devices 9. Subjects will have used the Vype ePen 3 and/or Vype ePod vaping devices for a minimum of 6 months prior to Screening 10. Subjects will have a urine cotinine level > 200 ng/mL and an exhaled breath CO level 200ng/ml and an exhaled breath CO level =7 ppm at Screening Additional criteria for Arm C subjects only: 14. Subjects will be former smokers of commercially manufactured filter cigarettes who quit smoking at least 6 months prior to Screening 15. Subjects will have a urine cotinine level < 200 ng/ml and an exhaled breath CO level <7 ppm at Screening Additional criteria for Arm D subjects only: 16. Subjects will have never smoked (<100 cigarettes in their life and none within the six months prior to Screening) 17. Subjects will have a urine cotinine level < 200 ng/ml and an exhaled breath CO level <7 ppm at Screening
Exclusion criteria
Exclusion criteria: All Subjects: 1. Female subjects who are pregnant or breastfeeding. This will be confirmed at Screening 2. Subjects who have donated: 2.1. =400 ml of blood within 90 days prior to screening 2.2. Plasma in the 7 days prior to screening 2.3. Platelets in the 6 weeks prior to screening 3. Subjects who have had an acute illness (e.g. upper respiratory tract infection, viral infection, etc.) requiring treatment within 4 weeks prior to screening 4. Subjects who have a significant history of alcoholism or drug/chemical abuse (apart from known smoking/vaping history) within 24 months prior to Screening, as determined by the PI or the appropriately qualified designee 5. Subjects who have a positive urine drugs of abuse or breath alcohol screen (confirmed by repeat) at Screening 6. Subjects who: 6.1. Have serum hepatitis/are carriers of the hepatitis B surface antigen (HBsAg) 6.2. Are carriers of the hepatitis C antibody 6.3. Have a positive result for the test for human immunodeficiency virus (HIV) antibodies 6.4. have a positive result in the COVID test at screening indicating current, active infection 7. Subjects who have used prescription or over-the-counter (OTC) bronchodilator medication (e.g. inhaled or oral ß-adrenergic agonists) to treat a chronic condition within the 12 months prior to screening 8. Subjects who have received any medications or substances (other than nicotine) which: 8.1. Interfere with the cyclooxygenase pathway (e.g. anti-inflammatory drugs including aspirin and ibuprofen) within 14 days prior to Screening 8.2. Are known to be strong inducers or inhibitors of cytochrome P450 (CYP) enzymes within 14 days or 5 half-lives of the drug (whichever is longer) prior to Screening 9. Subjects who would need to take prescription medication during the period beginning with screening and ending with discharge 10. Subjects who are unwilling or unable to comply with the study requirements 11. Employees and immediate relatives of the tobacco industry or the clinical site 12. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests or clinical laboratory panel, unless deemed not clinically significant by the PI or the appropriately qualified designee 13. Subjects who have been diagnosed with a significant history of urticaria or asthma (childhood asthma is acceptable) 14. Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal (including urinary tract infection or nephrolithiasis), hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI or the appropriately qualified designee, would jeopardise the safety of the subject or impact on the validity of the study results 15. Subjects who have previously been diagnosed with any form of malignancy 16. Subjects who are currently participating in another clinical trial (including follow-up) 17. Subjects who, in the opinion of the PI or the appropriately qualif
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint: 1. Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) is measured in 24-hour urine void using a validated LC-MS/MS method 2. Nitric oxide is measured in exhaled breath (FeNO) using a handheld monitor containing an electrochemical sensor 3. 8-epi-prostaglandin F2a Type III (8-Epi-PGF2a Type III) is measured in 24-hour urine void using a validated LC-MS/MS method 4. Carboxyhaemoglobin (COHb) is measured in blood using a validated GC-MS method 5. Total white blood cell count (WBC) is measured in blood using an automated haematology sampling procedure 6. Soluble intercellular adhesion molecule-1 (s-ICAM1) is measured in blood using a validated ELISA/CLIA method 7. High-density lipoprotein (HDL) is measured in blood using a homogenous enzymatic colorimetry method | — |
Secondary
| Measure | Time frame |
|---|---|
| Measured at a single timepoint: 1. 11-dehydrothromboxane B2 (11-dTX B2) is measured in 24-hour urine void using a validated LC-MS/MS method 2. Total nicotine equivalents (nicotine, cotinine, 3-hydroxycotinine and their glucuronide conjugates) (TNeq) is measured in 24-hour urine void using a validated LC-MS/MS method 3. Monohydroxybutenylmercapturic acid (MHBMA) in 24-hour urine void using a validated LC-MS/MS method 4. 3-hydroxy-1-methylpropylmercapuric acid (HMPMA) in 24-hour urine void using a validated LC-MS/MS method 5. 3-hydroxypropylmercapturic acid (3-HPMA) in 24-hour urine void using a validated LC-MS/MS method 6. Total N-nitrosonornicotine (Total NNN) in 24-hour urine void using a validated LC-MS/MS method 7. 3-hydroxybenzo[a]pyrene (3-OH-B[a]P) in 24-hour urine void using a validated LC-MS/MS method 8. Forced Expiratory Volume in 1 second as % of predicted (FEV1%pred) is measured using a spirometer 9. Carotid intima-media thickness (CIMT) is measured using ultrasonography 10. Quality of life is measured using the validated RAND 36-Item Health Survey 1.0 Questionnaire Items (SF-36) Added 20/08/2021: 11. S-phenylmercapturic acid (S-PMA) in 24-hour urine void measured using a validated LC-MS/MS method | — |
Countries
England, United Kingdom
Outcome results
None listed