Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

N/ACompletedNCT01970995

Philip Morris Products S.A.160 enrolled

Overview

The main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke 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)

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 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 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 cytochrome P450 1 A2 (CYP1A2) or cytochrome P450 2 A6 (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.

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 (LS) 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 (LS) 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

Concentration 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 are provided as descriptive statistics.

Time frame: 90 days

Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

Overview

Conditions

Interventions

Eligibility

Locations (1)

Outcomes

Primary Outcomes