Reduced Exposure Study Using THS 2.2 Menthol With 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

Smoking Clinical Trial

Official title:

A Randomized, Controlled, Multi-center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Smokers Switching to THS 2.2 Menthol or Smoking Abstinence Compared to Smoking Menthol Conventional Cigarettes, for 90 Days

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01970995
• Other study ID #: ZRHM-REXA-07-JP
• Secondary ID: ZRHM-REXA-07-JP
• Status: Completed
• Phase: N/A
• Start date: August 2013
• Est. completion date: November 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 main goal of the study is to evaluate if the ad libitum use of the THS 2.2 Menthol (mTHS 2.2) for 5 days in confinement and after 85 days of product use in an ambulatory setting, by Japanese adult healthy smokers results in a reduction in the levels of biomarkers of exposure for selected harmful and potentially harmful smoke 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2014
• Est. primary completion date: July 2014
• 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 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 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 cytochrome P450 1 A2 (CYP1A2) or cytochrome P450 2 A6 (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:
• THS 2.2 Menthol (mTHS 2.2)
THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting
• Smoking Abstinence (SA)
SA for 5 days in confinement prolonged by 85 days in an ambulatory setting
• Menthol Conventional Cigarette (mCC)
Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

Locations

Country	Name	City	State
Japan	Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-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 (LS) 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 (LS) 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
Primary	Concentration of Total 4-(Methylnitrosamino)-1-(3- Pyridyl)-1-butanol) (Total NNAL)	Concentrations measured at Day 90 in urine, adjusted for creatinine.; Geometric Least Squares (LS) means are provided as descriptive statistics.	90 days