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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.

Tracking Information
First Submitted Date  ICMJE May 7, 2015
First Posted Date  ICMJE June 9, 2015
Results First Submitted Date  ICMJE February 17, 2017
Results First Posted Date  ICMJE April 11, 2017
Last Update Posted Date May 13, 2020
Study Start Date  ICMJE May 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 28, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: June 8, 2015)
  • Ratio of the maximum concentration (Cmax) of nicotine following single use of CHTP 1.1 M and mCC [ Time Frame: 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) ]
  • Ratio of the 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: 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) ]
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Nicotine Pharmacokinetic Profile of the CHTP 1.1 M
Official Title  ICMJE 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
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smoking
Intervention  ICMJE
  • 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)
Study Arms  ICMJE
  • 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).
    Interventions:
    • Other: CHTP 1.1 M
    • Other: 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).
    Interventions:
    • Other: CHTP 1.1 M
    • Other: mCC
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 28, 2017)
56
Original Estimated Enrollment  ICMJE
 (submitted: June 8, 2015)
48
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date August 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02466412
Other Study ID Numbers  ICMJE P2M-PK-04-JP
P2M-PK-04-JP ( Other Identifier: Philip Morris Products S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Philip Morris Products S.A.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Philip Morris Products S.A.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Christelle Haziza, PhD Philip Morris Products S.A.
Principal Investigator: Fumimasa Nobuoka, MD Ageo Medical Clinic
PRS Account Philip Morris Products S.A.
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP