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

Smoking Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970982
• Other study ID #: ZRHR-REXC-04-JP
• Secondary ID: ZRHR-REXC-04-JP
• Status: Completed
• Phase: N/A
• Start date: July 2013
• Est. completion date: July 2014

Study information

• Verified date: March 2020
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 166
• Est. completion date: July 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 23 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• Tobacco Heating System (THS 2.2)
THS 2.2 ad libitum for 5 days in confinement
• Smoking abstinence (SA)
SA for 5 days in confinement
• Conventional cigarette (CC)
Subject's own preferred brand of CC ad libitum for 5 days in confinement

Locations

Country	Name	City	State
Japan	Higashi Shinjuku Clinic, Daito Building, 1-11-3, Okubo, Shinjuku-ku	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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