Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

85 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-07-31

Study Completion Date

2016-03-31

Brief Summary

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The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.

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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 1.0

Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement

Group Type EXPERIMENTAL

CHTP 1.0

Intervention Type OTHER

CHTP 1.0 ad libitum for 5 days in confinement

Conventional cigarette (CC)

Ad libitum use of subject's own preferred brand of CC for 5 days in confinement

Group Type ACTIVE_COMPARATOR

Conventional Cigarette (CC)

Intervention Type OTHER

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Interventions

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CHTP 1.0

CHTP 1.0 ad libitum for 5 days in confinement

Intervention Type OTHER

Conventional Cigarette (CC)

Subject's own preferred brand of CC ad libitum for 5 days in confinement

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is aged ≥ 21 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
* Subject has smoked at least for the last 3 years.
* Subject does not plan to quit smoking in the next 3 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

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes