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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: Tobacco Heating System (THS 2.2); Other: Smoking abstinence (SA); Other: Conventional cigarette (CC)

• Registration Number: NCT01970982
• Lead Sponsor: Philip Morris Products S.A.

Brief Summary

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2013-07
• Study First Submitted: 2013-10-18
• Study First Submitted QC: 2013-10-26
• Study First Posted: 2013-10-28
• Primary Completion: 2013-12
• Study Completion: 2014-07
• Results First Submitted: 2016-01-26
• Results First Submitted QC: 2016-08-19
• Results First Posted: 2016-10-17
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 166

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tobacco Heating System (THS 2.2)	Tobacco Heating System (THS 2.2)	Ad libitum use of THS 2.2 for 5 days in confinement
Smoking abstinence (SA)	Smoking abstinence (SA)	Abstinence from smoking for 5 days in confinement
Conventional cigarette (CC)	Conventional cigarette (CC)	Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement

Primary Outcome Measures

Name	Time	Method
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 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 means are provided as descriptive statistics.
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.

Trial Locations

Locations (1)

Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku; 🇯🇵 Tokyo, Japan