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Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01967706
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : February 2, 2016
Last Update Posted : March 18, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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Brief Summary:
The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).

Condition or disease Intervention/treatment Phase
Smoking Other: mTHS Other: mCC Other: NRT Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 73 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-center, Open-label, Randomized, Controlled, Crossover Study to Investigate the Nicotine Pharmacokinetic Profile and Safety of Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes and Nicotine Gum.
Study Start Date : August 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : May 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: mTHS then mCC

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mTHS)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mCC).
 Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS)

Other: mCC
Single use of subject's own menthol cigarette (mCC)
Active Comparator: mCC then mTHS

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mCC)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mTHS).
 Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS)

Other: mCC
Single use of subject's own menthol cigarette (mCC)
Active Comparator: mTHS then NRT

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of mTHS)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single administration of NRT)
 Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS)

Other: NRT
Single administration of 2 mg gum (Nicorette® 2mg)
Active Comparator: NRT then mTHS

Each subject will follow the below study design:

  • Day 0 = Wash-out (1 day)
  • Day 1 = 1st intervention (single administration of NRT)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mTHS).
 Other: mTHS
Single use of Tobacco Heating System 2.2 Menthol (mTHS)

Other: NRT
Single administration of 2 mg gum (Nicorette® 2mg)


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS, mCC and NRT [ Time Frame: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0 ]

    T0 = start of single product use.

    Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).

    Geometric Least Squares means are provided.


  2. Area Under the Plasma Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS, mCC and NRT [ Time Frame: Blood taken 15 minutes prior to T0, 2, 4, 6, 8, 10, 15, 30, 45 minutes, 1, 2, 4, 6, 9, 12, and 24 hours after T0 ]

    T0 = start of single product use.

    Derived from multiple blood sampling on Day 1 and Day 3 (1 blood sampling pre-product use and multiple blood sampling over 24 hours post-product use).

    Geometric Least Squares means are provided.



Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   23 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is Japanese.
  • Smoking, healthy subject as judged by the Investigator.
  • Subject has smoked at least 10 commercially available mCCs 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 a medication (whichever is longer) which has an impact on CYP2A6 activity.
  • Female subject is pregnant or breast feeding.
  • Female subject does not agree to use an acceptable method of effective contraception.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01967706


Locations
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Japan
Ageo Medical Clinic, 3133 Haraichi, Ageo-shi
Saitama, Japan, 362 0021
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Fumimasa Nobuoka, MD Ageo Medical Clinic
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] June 21, 2013
Statistical Analysis Plan  [PDF] May 8, 2014

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01967706    
Other Study ID Numbers: ZRHM-PK-05-JP
ZRHM-PK-05-JP ( Other Identifier: Philip Morris Products S.A. )
First Posted: October 23, 2013    Key Record Dates
Results First Posted: February 2, 2016
Last Update Posted: March 18, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Philip Morris Products S.A.:
Smoking
Nicotine absorption
Candidate modified risk tobacco product
 Cigarette
Nicotine replacement therapy
Nicotine gum