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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

121 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CHTP 1.2

Ad libitum use of the CHTP 1.2

Group Type EXPERIMENTAL

CHTP 1.2

Intervention Type OTHER

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

CC

Ad libitum use of subject's own preferred non-menthol brand of CC

Group Type ACTIVE_COMPARATOR

CC

Intervention Type OTHER

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.

Interventions

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CHTP 1.2

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

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is aged ≥ 28 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
* Subject has smoked at least for the last 10 years.
* Subject does not plan to quit smoking in the next 6 months.

Exclusion Criteria

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Minimum Eligible Age

28 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes