Reduced Exposure Study in Smokers Using THS 2.2 With 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

NCT01959932

ZRHR-REXC-03-EU (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 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) for selected harmful and potentially harmful constituents (HPHCs) compared to smoking conventional cigarettes (CC) and smoking abstinence (SA).

Enrollment: 169 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is Caucasian.
• Current healthy smoker as judged by the Principal Investigator.
• Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
• 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).
• 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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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169 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)