Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
- Conditions
- Smoking
- Interventions
- Other: THS 2.2 Menthol (mTHS 2.2)Other: Smoking Abstinence (SA)Other: Menthol Conventional Cigarette (mCC)
- Registration Number
- NCT01970995
- Lead Sponsor
- Philip Morris Products S.A.
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 160
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description THS 2.2 Menthol (mTHS 2.2) THS 2.2 Menthol (mTHS 2.2) Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting Smoking abstinence (SA) Smoking Abstinence (SA) Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting Menthol Conventional Cigarette (mCC) Menthol Conventional Cigarette (mCC) Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting
- Primary Outcome Measures
Name Time Method Levels of Carboxyhemoglobin (COHb) 5 days % 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.Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) 5 days Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) 5 days Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.Concentration of S-phenylmercapturic Acid (S-PMA) 5 days Concentrations measured at Day 5 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL) 90 days Concentrations measured at Day 90 in urine, adjusted for creatinine.
Geometric Least Squares (LS) means are provided as descriptive statistics.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku
šÆšµTokyo, Japan