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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: Conventional cigarette (CC); Other: Smoking abstinence (SA); Other: Tobacco Heating System (THS 2.2)

Study type: Interventional

Funder types: Industry

Identifiers

NCT01970982

ZRHR-REXC-04-JP (Other Identifier)

Details and patient eligibility

About

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).

Enrollment: 166 patients

Sex: All

Ages: 23 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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166 participants in 3 patient groups

Tobacco Heating System (THS 2.2)

Experimental group

Description:

Ad libitum use of THS 2.2 for 5 days in confinement

Treatment:

Other: Tobacco Heating System (THS 2.2)

Smoking abstinence (SA)

Sham Comparator group

Description:

Abstinence from smoking for 5 days in confinement

Treatment:

Other: Smoking abstinence (SA)

Conventional cigarette (CC)

Active Comparator group

Description:

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

Treatment:

Other: Conventional cigarette (CC)