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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

NCT05142436 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 806

Last updated 2022-12-16

No results posted yet for this study

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.

Conditions

  • Smoking
  • Tobacco Use
  • Tobacco Smoking

Interventions

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

Sponsors & Collaborators

  • Celerion

    collaborator INDUSTRY

  • British American Tobacco (Investments) Limited

    lead INDUSTRY

Principal Investigators

  • Nathan Gale · BAT

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
26 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-01-13
Primary Completion
2022-12-13
Completion
2022-12-13

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05142436 on ClinicalTrials.gov