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

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ClinicalTrials.gov Identifier: NCT01967706
Recruitment Status : Completed
First Posted : October 23, 2013
Results First Posted : February 2, 2016
Last Update Posted : September 5, 2017
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date  ICMJE October 18, 2013
First Posted Date  ICMJE October 23, 2013
Results First Submitted Date  ICMJE June 10, 2015
Results First Posted Date  ICMJE February 2, 2016
Last Update Posted Date September 5, 2017
Study Start Date  ICMJE August 2013
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 4, 2017)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: October 22, 2013)
Nicotine maximum plasma concentration (Cmax) and area under the nicotine concentration-time curve from start of product use to time of last quantifiable concentration [AUC(0-last)]. [ Time Frame: 1 day ]
To evaluate the rate and amount of nicotine absorption from THS 2.2 Menthol relative to mCC, following a single use of THS 2.2 Menthol and mCC
Change History Complete list of historical versions of study NCT01967706 on ClinicalTrials.gov Archive Site
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 and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol).
Official Title  ICMJE 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.
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).
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: mTHS
    Single use of Tobacco Heating System 2.2 Menthol (mTHS)
  • Other: mCC
    Single use of subject's own menthol cigarette (mCC)
  • Other: NRT
    Single administration of 2 mg gum (Nicorette® 2mg)
Study Arms  ICMJE
  • 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).
    Interventions:
    • Other: mTHS
    • Other: 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).
    Interventions:
    • Other: mTHS
    • Other: 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)
    Interventions:
    • Other: mTHS
    • Other: NRT
  • 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).
    Interventions:
    • Other: mTHS
    • Other: NRT
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 19, 2014)
73
Original Estimated Enrollment  ICMJE
 (submitted: October 22, 2013)
190
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 23 Years to 65 Years   (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 NCT01967706
Other Study ID Numbers  ICMJE ZRHM-PK-05-JP
ZRHM-PK-05-JP ( Other Identifier: Philip Morris Products S.A. )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Philip Morris Products S.A.
Study Sponsor  ICMJE Philip Morris Products S.A.
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 August 2017

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