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

N/ACompletedNCT01970982

Philip Morris Products S.A.166 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

166

Conditions

Smoking

Interventions

Tobacco Heating System (THS 2.2)OTHER

THS 2.2 ad libitum for 5 days in confinement

Smoking abstinence (SA)OTHER

SA for 5 days in confinement

Conventional cigarette (CC)OTHER

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

Eligibility

Sex: ALLMin age: 23 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku

Tokyo, Japan

Outcomes

Primary Outcomes

Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)

Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares LS) means are provided as descriptive statistics.

Time frame: 5 days

Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

Time frame: 5 days

Concentration of S-phenylmercapturic Acid (S-PMA)

Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.

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 means are provided as descriptive statistics.

Time frame: 5 days

Data from ClinicalTrials.gov

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