Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting Followed by 86 Days in an Ambulatory Setting

N/ACompletedNCT01989156

Philip Morris Products S.A.160 enrolled

Overview

Evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs).

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS) for 5 days in confinement, and after 86 days in an ambulatory setting, by apparently adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) compared to smokers continuing smoking their own preferred brand of menthol conventional cigarette (mCC) and smoking abstinence (SA). Smokers who remained abstinent from SA were used as a benchmark to provide context to the exposure reduction.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

160

Conditions

Smoking

Interventions

THS 2.2 Menthol (mTHS 2.2)OTHER

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Menthol Conventional Cigarette (mCC)OTHER

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 86 days in an ambulatory setting

Smoking Abstinence (SA)OTHER

SA for 5 days in confinement prolonged by 86 days in an ambulatory setting

Eligibility

Sex: ALLMin age: 22 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Smoking, apparently healthy subject as judged by the Investigator. * Subject smokes at least 10 commercially available mCCs 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 within 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). * 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 (2)

Covance Daytona Beach, 1900 Mason Ave., Suite 140

Daytona Beach, Florida, United States

Covance Dallas, 1341 W. Mockingbird Ln., Ste 400E

Dallas, Texas, United States

Outcomes

Primary Outcomes

Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)

Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

Time frame: 5 days

Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

Time frame: 5 days

Concentration of S-phenylmercapturic Acid (S-PMA)

Concentrations measured in urine, adjusted for creatinine, at Day 5 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

Time frame: 5 days

Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)

Concentrations measured in urine, adjusted for creatinine, at Day 90 for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

Time frame: 90 days

Levels of Carboxyhemoglobin (COHb)

Carboxyhemoglobin (COHb) is assayed from whole blood. Expressed as % of saturation of hemoglobin. Blood measurements performed in the evening of Day 5, for the smokers of all arms (mTHS, mCC and SA). Geometric Least Squares means are provided as descriptive statistics.

Time frame: 5 days

Data from ClinicalTrials.gov

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