Nicotine uptake Other
Conditions
Interventions
Participants:
1. Stay at the research site for 8 days.
2. Undergo a training session for how to correctly use the different nicotine products.
3. Following a successful training session, participants
Sponsors
British American Tobacco (United Kingdom)
Nicoventures Trading Limited
Eligibility
Sex/Gender
All
Age
19 Years to 55 Years
Inclusion criteria
Inclusion criteria: 1. Able to read, understand, and willing to sign an informed consent form (ICF) and complete questionnaires written in English 2. Stated willingness to comply with all study procedures and availability for the duration of the study 3. Adult male or female 4. If female, and is of childbearing potential and agrees to use one of the accepted contraceptive regimens from at least 28 days prior to the first study product administration through to at least 30 days after the last use of study product. 5. Aged at least 19 years but not older than 55 years 6. Body mass index (BMI) within 18.5 kg/m2 to 30.0 kg/m2, inclusively 7. Minimal body weight of 50 kg 8. Primary tobacco product used in the last 6 months is combustible cigarettes or roll your own cigarettes 9. A smoker of 10 cigarettes or more per day who has smoked for at least 6 months prior to the first study product administration, except for brief periods of abstinence due to illness, quit attempt (prior to 28 days of Screening), or clinical study participation (prior to 28 days of Screening) will be allowed at the discretion of an investigator 10. Response at Screening to the Fagerström Test for Nicotine Dependence (FTND) Question 1 (“How soon after you wake up do you smoke your first cigarette?”) is either “Within 5 minutes” or “6-30 minutes”. 11. Stated willingness to abstain from nicotine and tobacco products (except for the study products provided) from 24 hours prior to the first study product administration until the end of the study 12. Positive urine cotinine test (=200 ng/mL) at Screening and prior to the first study product administration 13. Expired breath carbon monoxide (eCO) level is =10 ppm and =100 ppm at Screening and at check-in (Day -2) 14. Successful completion of the training session for study product use prior to the first study product administration (participant is able to follow the instructions and does not experience significant AEs during the training session) 15. Clinical laboratory values within the laboratory's stated normal range; if not within this range, they must be without clinical significance, as determined by an investigator 16. Have no clinically significant diseases captured in the medical history or evidence of clinically significant findings on the physical examination (including oral mucosa examination and vital signs) and/or ECG, as determined by an investigator
Exclusion criteria
Exclusion criteria: 1. Females who have a positive pregnancy test, are pregnant, breastfeeding, or intend to become pregnant during the course of the study 2. Presence of any tongue piercings or history of any tongue piercings in the last 90 days prior to the first study product administration 3. Presence of braces, partials, dentures or any dental work that could, in the opinion of an investigator, affect the conduct of the study (including missing molars) 4. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction 5. Use of tobacco and/or nicotine containing products, other than combustible cigarettes, (e.g., e-cigarette/vapes pods, tanks, nicotine-containing pouches or disposables, or heated tobacco products) more than one day per week for the past 6 months prior to Screening or at any time in the last 28 days 6. History of significant hypersensitivity to any excipients of the formulations as well as severe hypersensitivity reactions (like angioedema) to any drugs 7. Presence or history of significant gastrointestinal, liver or kidney disease, or surgery that may affect drug bioavailability 8. History of significant cardiovascular, pulmonary, hematologic, neurological, psychiatric, endocrine, immunologic or dermatologic disease 9. Presence of clinically significant ECG abnormalities at the Screening visit, as defined by medical judgment 10. Maintenance therapy with any drug (with the exception of hormonal contraceptives or hormone replacement therapy) 11. Significant history of drug dependency or alcohol abuse (> 14 units of alcohol per week, intake of excessive alcohol, acute or chronic) 12. Any clinically significant illness in the 28 days prior to the first study product administration 13. Use of any prescription drugs (with the exception of hormonal contraceptives or hormone replacement therapy) in the 28 days prior to the first study product administration, that in the opinion of an investigator would put into question the status of the participant as healthy 14. Use of all formats of pseudoephedrine in the 7 days prior to the first study product administration 15. Use of any medication or substance that aids in smoking cessation, including but not limited to any nicotine replacement therapy (e.g., nicotine gum, lozenge, patch), varenicline (Chantix®), bupropion (Wellbutrin®, Zyban®), or Lobelia extract in the 28 days prior to the first study product administration 16. Any history of tuberculosis 17. Positive test result for alcohol and/or drugs of abuse at Screening or prior to the first product administration. 18. Positive Screening results for HIV Ag/Ab Combo, Hepatitis B surface Antigen (HBsAG (B) (hepatitis B)) or Hepatitis C Virus (HCV (C)) tests 19. Inclusion in a previous group for this clinical study 20. Intake of an Investigational Product in any other clinical trial in the 28 days prior to the first study product administration 21. Haemoglobin level is <12.5 g/dL for females or <13.5 g/dL for males at Screening 22. Donation of 500 mL or more of whole blood or lost blood or blood products in the 56 days prior to the first study product administration 23. Plasma donation within (=) 7 days prior to signing the informed consent or between Screening and check-in Day -2 24. A postponement of a decision to quit using tobacco- or nicotine-containing products in order to participate in this study 25. Previously attempted to quit using tobacco- or nicoti
Countries
Northern Ireland, United Kingdom
Contacts
Public ContactOlivia Tookey
Outcome results
None listed