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

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: CHTP 1.0; Other: Conventional Cigarette (CC)

Study type: Interventional

Funder types: Industry

Identifiers

NCT02503254

P2R-REXC-06-EU (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 85 patients

Sex: All

Ages: 21+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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85 participants in 2 patient groups

CHTP 1.0

Experimental group

Description:

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

Treatment:

Other: CHTP 1.0

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)