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Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

NCT02641587 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2023-02-21

Study results available
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Summary

The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.

Conditions

  • Smoking

Interventions

OTHER

CHTP 1.2

Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

OTHER

CC

Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Sponsors & Collaborators

  • Philip Morris Products S.A.

    lead INDUSTRY

Principal Investigators

  • Christelle Haziza, PhD · Philip Morris Products S.A.

  • Monika Tomaszewska-Kiecana, MD · BioVirtus Research Site

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
28 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-01-31
Primary Completion
2016-08-31
Completion
2017-07-31

Countries

  • Poland

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 NCT02641587 on ClinicalTrials.gov