NCT05142436

BAT3221032: A Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects

BAT3221032: A Randomized, Controlled Study to Evaluate the Effects of Switching From Cigarette Smoking to Using One of Five Variants of a Heated Tobacco Product on Biomarkers of Exposure and Biomarkers of Potential Harm in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 806 (actual)
• Sponsor: British American Tobacco (Investments) Limited · Industry
• Sex: All
• Age: 26 Years – 55 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, controlled, multi-center, open-label, 8-cohort parallel group study to assess changes in select biomarkers of exposure (BoE) and biomarkers of potential harm (BoPH) in generally healthy smokers switching to the study investigational products (IPs), compared to subjects who continue to smoke, undergo smoking abstinence, or have never smoked.

Detailed description

All subjects will participate in a baseline biomarker assessment and smokers will then be switched to exclusive use of their assigned product (cohorts 1-5), continue to smoke (cohort 6), or smoking cessation (cohort 7), and never-smokers will continue to not smoke (cohort 8). Subjects will be directed to use their assigned product exclusively for 3 months and will participate in study visits throughout the study for safety, product re-supply and collection of samples for biomarker assessments. Throughout the study, subjects will report their daily use of the study IP and/or cigarette smoking. This study will be ambulatory, with subjects in cohorts 1-7 attending a total of 4 clinic visits (one every approximately 30 days) over a period of 3 months. Subjects in cohorts 1-7 will be confined in the study site overnight the night before their Day 1 (Visit 1, baseline) and Day 90 (Visit 4) visits. The Day 30 (Visit 2) and Day 60 (Visit 3) visits will be non-residential visits for pregnancy testing (female subjects) and product usage assessments and resupply only. Subjects in cohort 8 will attend the clinic for Visit 1 and Visit 4 only, and will be confined in the clinic overnight the night before each of these visits. In addition, all subjects will attend a Screening Visit. Smokers will be asked to continue smoking their usual brand (UB) cigarettes until randomization (cohorts 1-6) or enrollment (cohort 7) at Visit 1. Never-smokers will be asked to continue not to use any tobacco or nicotine products for the entire study duration. All subjects will be confined on Visit 1 and will use their UB cigarettes ad libitum during this period (unless required to abstain for specific tests and excluding cohort 8, who will not use any nicotine or tobacco products). Exhaled breath, 24-hour urine and blood samples will be collected and evaluated for baseline BoE and BoPH. Smokers of non-menthol UB cigarettes will then be randomized to cohort 1, 5 or 6; smokers of mentholated UB cigarettes will be randomized to cohort 2, 3, 4 or 6; smokers who intend to quit smoking will be enrolled to cohort 7; and never-smokers will be enrolled to cohort 8. All subjects will be confined on Visit 4. Subjects in cohorts 1-6 will use their assigned product exclusively, ad libitum during this period (unless required to abstain for specific tests). Other than subjects in cohort 7 who are using nicotine replacement therapy as part of their smoking cessation strategy, subjects in cohorts 7 and 8 will not use any tobacco or nicotine products. Exhaled breath, 24-hour urine and blood samples will be collected and evaluated for BoE and BoPH.

Conditions

• Smoking
• Tobacco Use
• Tobacco Smoking

Interventions

Type	Name	Description
OTHER	Product A: Non-Combusted Cigarette Variant 42001402 and product use Mode B	42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
OTHER	Product B: Non-Combusted Cigarette Variant 42001399 and product use Mode B	42001399, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
OTHER	Product C: Non-Combusted Cigarette Variant 42001401 and product use Mode B	42001401, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
OTHER	Product D: Non-Combusted Cigarette Variant 40007386 and product use Mode B	40007386, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode B
OTHER	Product E: Non-Combusted Cigarette Variant 42001402 and product use Mode A	42001402, A Heated Tobacco Product using a Non-Combusted Cigarette Variant and product use Mode A

Timeline

• Start date: 2022-01-13
• Primary completion: 2022-12-13
• Completion: 2022-12-13
• First posted: 2021-12-02
• Last updated: 2022-12-16

Locations

18 sites across 1 country: United States