Reduced Exposure Study in Smokers Using the Tobacco Heating System 2.2 (THS 2.2) for 5 Days in a Confinement Setting

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

166 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-07-31

Brief Summary

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The overall goal of the study is to evaluate if the ad libitum use of the Tobacco Heating System 2.2 (THS 2.2) for 5 consecutive days by adult Japanese healthy smokers affects the levels of biomarkers of exposure for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

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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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Tobacco Heating System (THS 2.2)

Ad libitum use of THS 2.2 for 5 days in confinement

Group Type EXPERIMENTAL

Tobacco Heating System (THS 2.2)

Intervention Type OTHER

THS 2.2 ad libitum for 5 days in confinement

Smoking abstinence (SA)

Abstinence from smoking for 5 days in confinement

Group Type SHAM_COMPARATOR

Smoking abstinence (SA)

Intervention Type OTHER

SA 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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Tobacco Heating System (THS 2.2)

THS 2.2 ad libitum for 5 days in confinement

Intervention Type OTHER

Smoking abstinence (SA)

SA 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 Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks, based on self reporting.
* Subject has smoked for at least the last 3 consecutive 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).
* The subject has received medication within 14 days or within 5 half-lives of the medication (whichever is longer), which has an impact on CYP1A2 or CYP2A6 activity.
* For women: Subject is pregnant or is breast feeding.
* For women: Subject does not agree to use an acceptable method of effective contraception.

Minimum Eligible Age

23 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes