A single-dose, randomised, crossover study to assess the pharmacokinetics of oral nicotine products and a cigarette in healthy adults who smoke combustible cigarettes and use smokeless pouch products

British American Tobacco (United Kingdom)0 sites35 target enrollmentApril 2, 2020

Overview

2021 Results article in https://pubmed.ncbi.nlm.nih.gov/34923602/ (added 20/12/2021)

Registry

who.int

Start Date

April 2, 2020

End Date

May 19, 2020

Last Updated

4 years ago

Study Type

Interventional

Sex

All

Sponsor

British American Tobacco (United Kingdom)

•1\. Provision of signed and dated informed consent form (ICF)
•2\. Stated willingness to comply with all study procedures and availability for the duration of the study
•3\. Healthy adult male or female
•4\. If female, meets one of the following criteria:
•4\.1\. Is of childbearing potential and agrees to use two 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 dose of study product. An acceptable method of contraception includes one of the following:
•4\.2\. Systemic contraceptives (combined birth control pills, injectable/implant/insertable hormonal birth control products, transdermal patch)
•4\.3\. Intrauterine device (with or without hormones)
•4\.4\. Barrier methods of contraception (male condom with spermicide, female condom, cervical cap, diaphragm, contraceptive sponge)
•4\.5\. Male partner vasectomised at least 6 months prior to the first study product administration
•4\.6\. Is of childbearing potential and agrees to abide by true abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle (not periodic abstinence)

•1\. Female who is lactating at screening
•2\. Female who is pregnant according to the pregnancy test at screening or prior to the first study product administration
•3\. Self\-reported non\-inhalers of cigarettes (smokers who draw the smoke from the cigarette into the mouth and throat but who do not inhale)
•4\. 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)
•5\. Presence or history of significant form of oral and/or pharyngeal inflammation, oral lesions and/or gum disease or temporomandibular joint dysfunction
•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) or significant history of drug dependency or alcohol abuse (\> 3 units of alcohol per day, intake of excessive alcohol, acute or chronic)