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

NCT01970995 | Completed Results

• 1 other identifier: ZRHM-REXA-07-JP
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Smoking

Keywords

Candidate modified risk tobacco product; Conventional cigarettes; Reduced exposure; HPHCs; Ambulatory

Outcome Measures

Primary Outcomes (5)

• 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 (LS) 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 (LS) 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

• 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

Study Arms (3)

THS 2.2 Menthol (mTHS 2.2)

EXPERIMENTAL

Ad libitum use of THS 2.2 Menthol for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

Other: THS 2.2 Menthol (mTHS 2.2)

Smoking abstinence (SA)

ACTIVE COMPARATOR

Abstinence from smoking for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

Other: Smoking Abstinence (SA)

Menthol Conventional Cigarette (mCC)

ACTIVE COMPARATOR

Ad libitum use of subject's own preferred brand of mCC for 5 Days in a Confinement Setting and 85 Days in an Ambulatory Setting

Other: Menthol Conventional Cigarette (mCC)

Interventions

THS 2.2 Menthol (mTHS 2.2) OTHER

THS 2.2 Menthol ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

THS 2.2 Menthol (mTHS 2.2)

Smoking Abstinence (SA) OTHER

SA for 5 days in confinement prolonged by 85 days in an ambulatory setting

Smoking abstinence (SA)

Menthol Conventional Cigarette (mCC) OTHER

Subject's own preferred brand of mCC ad libitum for 5 days in confinement prolonged by 85 days in an ambulatory setting

Menthol Conventional Cigarette (mCC)

Eligibility Criteria

• Age: 23 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Osaki Hospital Tokyo Heart Center, 5-4-12, Kitashinagawa, Shinagawa-ku

Tokyo, Japan

Location

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle HAZIZA, PhD
• Organization: Philip Morris Products S.A.

Christelle.Haziza@pmi.com

+41 (58) 242 2625

Study Officials

• Masahiro Endo, MD

  Osaki Hospital Tokyo Heart Center

  PRINCIPAL INVESTIGATOR

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 28, 2013
• Study Start: August 1, 2013
• Primary Completion: July 1, 2014
• Study Completion: November 1, 2014
• Last Updated: March 23, 2020
• Results First Posted: February 7, 2017

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

JP (1)