A randomised, controlled, multi-centre open-label study in healthy Japanese subjects to evaluate the effect on biomarkers of exposure of switching from a conventional combustible cigarette to the glo tobacco heating product.
- Conditions
- Cigarette smoking
- Registration Number
- JPRN-UMIN000024988
- Lead Sponsor
- British American Tobacco (Investments) Limited
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up continuing
- Sex
- All
- Target Recruitment
- 180
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method Biomarkers of Biological Effect (BoBE): 8-Epi-PGF2alpha Type III and white blood cell count. PK endpoints: tmax, Cmax and AUC0-last.