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Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.

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: NCT02503254
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : March 10, 2017
Last Update Posted : January 30, 2023
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date  ICMJE July 17, 2015
First Posted Date  ICMJE July 20, 2015
Results First Submitted Date  ICMJE November 4, 2016
Results First Posted Date  ICMJE March 10, 2017
Last Update Posted Date January 30, 2023
Study Start Date  ICMJE July 2015
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 19, 2017)
  • Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) [ Time Frame: 5 days ]
    Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics.
  • Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) [ Time Frame: 5 days ]
    Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
  • Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 5 days ]
    Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics.
  • Levels of Carboxyhemoglobin (COHb) [ Time Frame: 5 days ]
    % COHb blood measurements performed in the evening of Day 5, expressed as % of saturation of hemoglobin. Geometric Least Squares means are provided as descriptive statistics.
Original Primary Outcome Measures  ICMJE
 (submitted: July 17, 2015)
  • Ratio of the Concentrations of Monohydroxybutenyl Mercapturic Acid (MHBMA) in Smokers Switching From CC to CHTP 1.0 as Compared to Smokers Continuing to Smoke CC. [ Time Frame: Measured in 24-hour urine collection on Day 5 (starting day for the collection) ]
    Concentrations measured in urine, adjusted for creatinine.
  • Ratio of the Concentrations of 3-hydroxypropylmercapturic Acid (3-HPMA) in Smokers Switching From CC to CHTP 1.0 as Compared to Smokers Continuing to Smoke CC. [ Time Frame: Measured in 24-hour urine collection on Day 5 (starting day for the collection) ]
    Concentrations measured in urine, adjusted for creatinine.
  • Ratio of the Concentrations of S-phenylmercapturic Acid (S-PMA) in Smokers Switching From CC to CHTP 1.0 as Compared to Smokers Continuing to Smoke CC. [ Time Frame: Measured in 24-hour urine collection on Day 5 (starting day for the collection) ]
    Concentrations measured in urine, adjusted for creatinine.
  • Levels of Carboxyhemoglobin (COHb) in Smokers Switching From CC to CHTP 1.0 as Compared to Smokers Continuing to Smoke CC. [ Time Frame: Measured in blood on Day 5 ]
    Expressed as % of saturation of hemoglobin
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 Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.
Official Title  ICMJE A Randomized, Controlled, Open-label, 2-arm Parallel Group, Single Center Study to Demonstrate Reductions in Exposure to Selected Smoke Constituents in Healthy Smokers Switching to the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) Compared to Continuing to Use Conventional Cigarettes During 5 Days in Confinement.
Brief Summary The overall goal of the study is to demonstrate the reduction of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) in adult smokers switching for 5 days from conventional cigarette (CC) to Carbon Heated Tobacco Product 1.0 (CHTP 1.0) as compared to smokers continuing to use CC.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE Smoking
Intervention  ICMJE
  • Other: CHTP 1.0
    CHTP 1.0 ad libitum for 5 days in confinement
  • Other: Conventional Cigarette (CC)
    Subject's own preferred brand of CC ad libitum for 5 days in confinement
Study Arms  ICMJE
  • Experimental: CHTP 1.0
    Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
    Intervention: Other: CHTP 1.0
  • Active Comparator: Conventional cigarette (CC)
    Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
    Intervention: Other: Conventional Cigarette (CC)
Publications * Tran CT, Bosilkovska M, de La Bourdonnaye G, Blanc N, Haziza C. Reduced levels of biomarkers of exposure in smokers switching to the Carbon-Heated Tobacco Product 1.0: a controlled, randomized, open-label 5-day exposure trial. Sci Rep. 2020 Nov 5;10(1):19227. doi: 10.1038/s41598-020-76222-y.

*   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: January 19, 2017)
85
Original Estimated Enrollment  ICMJE
 (submitted: July 17, 2015)
80
Actual Study Completion Date  ICMJE March 2016
Actual Primary Completion Date September 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is aged ≥ 21 years.
  • Subject is Caucasian.
  • Subject is healthy, as judged by the Investigator.
  • Subject smokes at least 10 commercially available non-menthol CCs per day (no brand restrictions) for at least the last 6 weeks prior to admission, based on self-reporting.
  • Subject has smoked at least for the last 3 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 the medication (whichever is longer), which has an impact on cytochrome P450 1A2 (CYP1A2) or cytochrome P450 2A6 (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 21 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 Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02503254
Other Study ID Numbers  ICMJE P2R-REXC-06-EU
P2R-REXC-06-EU ( 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
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: Katarzyna Jarus-Dziedzic, MD, PhD BioVirtus Research Site
PRS Account Philip Morris Products S.A.
Verification Date January 2023

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