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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: Smoking Abstinence (SA); Other: Menthol Conventional Cigarette (mCC); Other: THS 2.2 Menthol (mTHS 2.2)

• Registration Number: NCT01989156
• Lead Sponsor: Philip Morris Products S.A.

Brief Summary

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).

Detailed Description

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 Timeline

• Study First Submitted: 2013-11-14
• Study First Submitted QC: 2013-11-19
• Study First Posted: 2013-11-20
• Study Start: 2013-12
• Primary Completion: 2014-10
• Study Completion: 2015-05
• Results First Submitted: 2016-12-21
• Results First Submitted QC: 2017-02-17
• Results First Posted: 2017-04-05
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-11
• Last Update Posted: 2020-03-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Smoking abstinence (SA)	Smoking Abstinence (SA)	Abstinence from smoking for 5 Days in a Confinement Setting and 86 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 86 Days in an Ambulatory Setting
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 86 Days in an Ambulatory Setting

Primary Outcome Measures

Name	Time	Method
Concentration of Monohydroxybutenylmercapturic Acid (MHBMA)	5 days	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.
Concentration of S-phenylmercapturic Acid (S-PMA)	5 days	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.
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	5 days	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.
Levels of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol (Total NNAL)	90 days	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.
Levels of Carboxyhemoglobin (COHb)	5 days	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.

Trial Locations

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