Reduced Exposure Study in Smokers Using THS 2.2 With 5 Days in a Confinement Setting.

Not Applicable

Completed

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

• Registration Number: NCT01959932
• 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 days by adult healthy smokers results in a reduction in the levels of biomarkers of exposure (BoExp) 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: 2013-06
• Primary Completion: 2013-09
• Study First Submitted: 2013-10-08
• Study First Submitted QC: 2013-10-09
• Study First Posted: 2013-10-10
• Study Completion: 2014-06
• Results First Submitted: 2016-01-26
• Results First Submitted QC: 2016-08-19
• Results First Posted: 2016-10-13
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-03
• Last Update Posted: 2020-03-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 169

Inclusion Criteria

• Subject is Caucasian.
• Current healthy smoker as judged by the Principal Investigator.
• Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) for the last 4 weeks.
• 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).
• 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 1A2 (CYP1A2) or cytochrome P450 2A6 (CYP2A6) activity.
• Female subject is pregnant or breast feeding.
• Female 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 confinement
Tobacco Heating System (THS 2.2)	Tobacco Heating System (THS 2.2)	Ad libitum use of THS 2.2 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 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 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 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)

BioVirtus Research Site Sp. z o.o.; 🇵🇱 Kajetany, Poland