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

A Controlled, 3-arm Parallel Group Study to Demonstrate Reduction in Exposure to Smoke Constituents in Healthy Smokers Switching to THS 2.2 or to Smoking Abstinence, Compared to Conventional Cigarettes for 5 Days in Confinement

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).

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: Tobacco Heating System (THS 2.2); Other: Smoking abstinence (SA); Other: Conventional cigarette (CC)

• Study Type: Interventional
• Enrollment (Actual): 166
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Japan
  • Tokyo, Japan
    • Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 23 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tobacco Heating System (THS 2.2); Ad libitum use of THS 2.2 for 5 days in confinement	Other: Tobacco Heating System (THS 2.2); THS 2.2 ad libitum for 5 days in confinement
Sham Comparator: Smoking abstinence (SA); Abstinence from smoking for 5 days in confinement	Other: Smoking abstinence (SA); SA for 5 days in confinement
Active Comparator: Conventional cigarette (CC); Ad libitum use of Subject's own preferred brand of CC for 5 days in confinement	Other: Conventional cigarette (CC); Subject's own preferred brand of CC ad libitum for 5 days in confinement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	5 days
Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)	Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.	5 days
Concentration of S-phenylmercapturic Acid (S-PMA)	Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.	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.	5 days

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Principal Investigator: Takuya Kunito, MD, Higashi Shinjuku Clinic

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): December 1, 2013
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: October 18, 2013
• First Submitted That Met QC Criteria: October 26, 2013
• First Posted (Estimate): October 28, 2013

Study Record Updates

• Last Update Posted (Actual): March 12, 2020
• Last Update Submitted That Met QC Criteria: March 3, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Confinement; Candidate modified risk tobacco product; Conventional cigarette; Reduced exposure; HPHCs
• Other Study ID Numbers: ZRHR-REXC-04-JP (Other Identifier: Philip Morris Products S.A.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No