Cigarette smoking
Conditions
Interventions
Regular cigarette smoking, for 5 days after 2 day baseline period.
Switch from regular cigarette smoking to developmental THP use for 5 days after 2 day baseline period.
Mentholated cigarette smoking,
Sponsors
British American Tobacco (Investments) Limited
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Subjects will be males or females of Japanese origin and between 23 and 55 years of age, inclusive. 2. Subjects will have a body mass index (BMI) between 17.6 and 32.0 kg/m2, inclusive; a body weight exceeding 50 kg (males) or 40 kg (females) 3. Subjects will be in good health, as judged by the PI or designee based on medical history, physical examination, vital signs assessment, 12-lead ECG, clinical laboratory evaluations and lung function tests 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 their 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 their appropriately qualified designee. 6. Subjects will be regular smokers of factory-made cigarettes whose chosen brand is within the ISO tar bands 6 mg to 8 mg. 7. Subjects will have smoked their chosen brand for a minimum of 6 months and will have smoked for at least 3 consecutive years prior to Screening. 8. Subjects will typically smoke at least 10 and a maximum of 30 cigarettes per day and must have a urine cotinine level >200 ng/mL and an exhaled breath CO level >10 ppm at Screening.
Exclusion criteria
Exclusion criteria: 1. Male subjects who do not agree, or whose partners of childbearing potential do not agree, to use a barrier method of contraception in addition to a second highly effective method of contraception used by their female partners or to refrain from donating sperm from Admission until the end of the safety Follow-up period. 2. Female subjects of childbearing potential who do not agree to use a highly effective method of birth control in conjunction with male barrier method contraception from the time of signing the ICF until the end of the safety Follow-up period. 3. Female subjects who are pregnant or breastfeeding. 4. Subjects who have an acute illness requiring treatment within 4 weeks prior to Admission. 5. Subjects who have regularly used any nicotine or tobacco product other than commercially manufactured filter cigarettes within 14 days of Screening. 6. Subjects who are self-reported non-inhalers. 7. Subjects who, prior to enrolment, are planning to quit smoking in the next 12 months. 8. Subjects who have serum hepatitis; are carriers of HBsAg; are carriers of the hepatitis C antibody; have a positive result for the test for HIV antibodies; or have syphilis. 9. Subjects who have used prescription or OTC bronchodilator medication to treat a chronic condition within the 12 months prior to Admission. 10. Subjects who have any clinically relevant abnormal findings on the physical examination, medical history, ECG, lung function tests or clinical laboratory panel. 11. Subjects who have, or who have a history of, any clinically significant neurological, gastrointestinal, renal, hepatic, cardiovascular, psychiatric, respiratory, metabolic, endocrine, haematological or other major disorder that, in the opinion of the PI, would jeopardise the safety of the subject or impact on the validity of the study results. 12. Subjects who have previously been diagnosed with any form of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biomarkers of exposure (BoE): CO, TNeq, total NNAL, total NNN, 3-HPMA, HMPMA, S-PMA, MHBMA, CEMA, 4-ABP, o-Tol, 2-AN, 1-OHP, HEMA, AAMA and GAMA. | — |
Secondary
| Measure | Time frame |
|---|---|
| Biomarkers of Biological Effect (BoBE): 8-Epi-PGF2alpha Type III and white blood cell count. PK endpoints: tmax, Cmax and AUC0-last. | — |
Countries
Japan
Contacts
Public ContactIan Fearon
British American Tobacco (Investments) Limited Clinical Research
Outcome results
None listed