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Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

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: NCT02466412
Recruitment Status : Completed
First Posted : June 9, 2015
Results First Posted : April 11, 2017
Last Update Posted : May 13, 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 of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.

Condition or disease Intervention/treatment Phase
Smoking Other: CHTP 1.1 M Other: mCC Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 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 of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M) Following Single Use in Smoking, Healthy Subjects Compared to Menthol Conventional Cigarettes
Study Start Date : May 2015
Actual Primary Completion Date : August 2015
Actual Study Completion Date : November 2015
Arms and Interventions
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Arm Intervention/treatment
Active Comparator: CHTP 1.1 M then mCC

Each subject will follow the below study design:

  • Day -1 = Wash-out (1 day)
  • Day 1 = 1st intervention (single product use of CHTP 1.1 M)
  • Day 2 = Wash-out
  • Day 3 = 2nd intervention (single product use of mCC).
 Other: CHTP 1.1 M
Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

Other: mCC
Single use of subject's own menthol conventional cigarette (mCC)
Active Comparator: mCC then CHTP 1.1 M

Each subject will follow the below study design:

  • Day -1 = 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 CHTP 1.1 M).
 Other: CHTP 1.1 M
Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

Other: mCC
Single use of subject's own menthol conventional cigarette (mCC)


Outcome Measures
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Primary Outcome Measures :
  1. Maximum Concentration (Cmax) of Nicotine Following Single Use of CHTP 1.1 M and mCC [ Time Frame: Day 3: 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 (LS) means are provided.


  2. Area Under the Plasma Concentration Versus Time Curve From Time Zero (Pre-product Use) to Last Time Point [AUC(0-last)] Following Single Use of CHTP 1.1 M and mCC [ Time Frame: Day 3: 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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Ages Eligible for Study:   23 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subject is Japanese.
  • Subject is at a minimum 23 years of age.
  • Smoking, healthy subject as judged by the Investigator.
  • Subject has smoked for at least the last 3 years
  • Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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): NCT02466412


Locations
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Japan
Ageo Medical Clinic
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] May 18, 2015
Statistical Analysis Plan  [PDF] November 17, 2015

More Information
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02466412    
Other Study ID Numbers: P2M-PK-04-JP
P2M-PK-04-JP ( Other Identifier: Philip Morris Products S.A. )
First Posted: June 9, 2015    Key Record Dates
Results First Posted: April 11, 2017
Last Update Posted: May 13, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
smoking
nicotine absorption
potential modified risk tobacco product
cigarette
Carbon Heated Tobacco Product