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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: NCT01967719
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : February 7, 2017
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 the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).

Condition or disease Intervention/treatment Phase
Smoking Other: mTHS 2.2 Other: mCC Other: NNS Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 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 Nasal Spray
Study Start Date : October 2013
Actual Primary Completion Date : November 2013
Actual Study Completion Date : May 2014
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: mTHS 2.2 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 2.2)
  • Day 2 = wash-out
  • Day 3 = 2nd intervention (single product use of mCC).
 Other: mTHS 2.2
Single use of mTHS 2.2

Other: mCC
Single use of subject's own mCC
Active Comparator: mCC then mTHS 2.2

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 2.2).
 Other: mTHS 2.2
Single use of mTHS 2.2

Other: mCC
Single use of subject's own mCC
Active Comparator: mTHS 2.2 then NNS

Each subject will follow the below study design:

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

Other: NNS
Single administration of 1 mg of nicotine
Active Comparator: NNS then mTHS 2.2

Each subject will follow the below study design:

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

Other: NNS
Single administration of 1 mg of nicotine


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of mTHS 2.2, mCC and NNS [ Time Frame: 3 days ]

    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 (geometric LS) means are provided.


  2. Area Under the Plasma Nicotine Concentration-Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of mTHS 2.2, mCC and NNS [ Time Frame: 3 days ]

    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

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Ages Eligible for Study:   22 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is aged from 22 to 65 years (inclusive).
  • Smoking, healthy subject as judged by the Investigator.
  • Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
  • Subject has smoked for at least the last 3 consecutive years.

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 drug (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): NCT01967719


Locations
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United States, Kentucky
Central Kentucky Research Associates
Lexington, Kentucky, United States, 40509
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: James L Borders, MD Central Kentucky Research Associates
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] May 22, 2013
Statistical Analysis Plan  [PDF] April 25, 2014

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT01967719    
Other Study ID Numbers: ZRHM-PK-06-US
ZRHM-PK-06-US ( Other Identifier: Philip Morris Products S.A. )
First Posted: October 23, 2013    Key Record Dates
Results First Posted: February 7, 2017
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
Conventional cigarette
Nicotine replacement therapy: nasal spray