Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

Philip Morris

Status: Completed

Conditions: Smoking

Treatments: Other: CHTP 1.2; Other: CC

Study type: Interventional

Funder types: Industry

Identifiers

NCT02641587

P2R-REXA-07-EU

Details and patient eligibility

About

The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.

Enrollment: 121 patients

Sex: All

Ages: 28+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Subject is aged ≥ 28 years.
• Subject is Caucasian.
• Subject is healthy, as judged by the Investigator.
• Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
• Subject has smoked at least for the last 10 years.
• Subject does not plan to quit smoking in the next 6 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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121 participants in 2 patient groups

CHTP 1.2

Experimental group

Description:

Ad libitum use of the CHTP 1.2

Treatment:

Other: CHTP 1.2

CC

Active Comparator group

Description:

Ad libitum use of subject's own preferred non-menthol brand of CC

Treatment:

Other: CC