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

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ClinicalTrials.gov Identifier: NCT02503254
Recruitment Status : Completed
First Posted : July 20, 2015
Results First Posted : March 10, 2017
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Other: CHTP 1.0 Other: Conventional Cigarette (CC) Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 85 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: 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.
Study Start Date : July 2015
Actual Primary Completion Date : September 2015
Actual Study Completion Date : March 2016
Arms and Interventions
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Arm Intervention/treatment
Experimental: CHTP 1.0
Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement
 Other: CHTP 1.0
CHTP 1.0 ad libitum for 5 days in confinement
Active Comparator: Conventional cigarette (CC)
Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
 Other: Conventional Cigarette (CC)
Subject's own preferred brand of CC ad libitum for 5 days in confinement


Outcome Measures
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Primary Outcome Measures :
  1. 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.


  2. 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.


  3. 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.


  4. 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.



Eligibility Criteria
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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
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): NCT02503254


Locations
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Poland
BioVirtus Research Site Sp. z o.o.
Kajetany, Poland, 05-830
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: Katarzyna Jarus-Dziedzic, MD, PhD BioVirtus Research Site
  Study Documents (Full-Text)

Documents provided by Philip Morris Products S.A.:
Study Protocol  [PDF] June 24, 2015
Statistical Analysis Plan  [PDF] March 21, 2016

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT02503254    
Other Study ID Numbers: P2R-REXC-06-EU
P2R-REXC-06-EU ( Other Identifier: Philip Morris Products S.A. )
First Posted: July 20, 2015    Key Record Dates
Results First Posted: March 10, 2017
Last Update Posted: March 27, 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
Modified risk tobacco product
Conventional cigarette
 Reduced exposure
Confinement
Carbon Heated Tobacco Product