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 Products S.A.121 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

121

Conditions

Smoking

Interventions

CHTP 1.2OTHER

Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

CCOTHER

Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

Eligibility

Sex: ALLMin age: 28 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

BioVirtus Research Site Sp. z o.o.

Nadarzyn, Poland

Outcomes

Primary Outcomes

Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)

Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time frame: 5 days

Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

Time frame: 5 days

Concentration of S-phenylmercapturic Acid (S-PMA)

Time frame: 5 days

Levels of Carboxyhemoglobin (COHb)

% COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Time frame: 5 days

Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)

Concentrations measured at Day 90 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

Data from ClinicalTrials.gov

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