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Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

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: NCT02641587
Recruitment Status : Completed
First Posted : December 29, 2015
Results First Posted : March 6, 2019
Last Update Posted : March 27, 2020
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

Tracking Information
First Submitted Date  ICMJE December 23, 2015
First Posted Date  ICMJE December 29, 2015
Results First Submitted Date  ICMJE October 2, 2018
Results First Posted Date  ICMJE March 6, 2019
Last Update Posted Date March 27, 2020
Actual Study Start Date  ICMJE January 2016
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 5, 2019)
  • Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA) [ Time Frame: 5 days ]
    Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
  • Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) [ Time Frame: 5 days ]
    Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
  • Concentration of S-phenylmercapturic Acid (S-PMA) [ Time Frame: 5 days ]
    Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
  • 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 (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
  • Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL) [ Time Frame: 90 days ]
    Concentrations measured at Day 90 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.
Original Primary Outcome Measures  ICMJE
 (submitted: December 23, 2015)
  • Ratio of the concentrations of monohydroxybutenylmercapturic acid (MHBMA) in smokers switching from CC to CHTP 1.2 as compared to smokers continuing to use CC for 5 days. [ Time Frame: 5 days ]
    Concentrations measured in urine, adjusted for creatinine.
  • Ratio of the concentrations of 3-hydroxypropylmercapturic acid (3-HPMA) in smokers switching from CC to CHTP 1.2 as compared to smokers continuing to use CC for 5 days. [ Time Frame: 5 days ]
    Concentrations measured in urine, adjusted for creatinine.
  • Ratio of the concentrations of S-phenylmercapturic acid (S-PMA) in smokers switching from CC to CHTP 1.2 as compared to smokers continuing to use CC for 5 days. [ Time Frame: 5 days ]
    Concentrations measured in urine, adjusted for creatinine.
  • Levels of carboxyhemoglobin (COHb) in smokers switching from CC to CHTP 1.2 as compared to smokers continuing to use CC for 5 days. [ Time Frame: 5 days ]
    Expressed as % of saturation of hemoglobin.
  • Ratio of the concentrations of total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL) in smokers switching from CC to CHTP 1.2 as compared to smokers continuing to use CC for 90 days. [ Time Frame: 90 days ]
    Concentrations measured in urine, adjusted for creatinine.
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 the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.
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 1.2 (CHTP 1.2), Compared to Continuing to Use Combustible Cigarettes, for 5 Days in Confinement Followed by 85 Days in an Ambulatory Setting.
Brief Summary The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.
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 1.2
    Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.
  • Other: CC
    Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.
Study Arms  ICMJE
  • Experimental: CHTP 1.2
    Ad libitum use of the CHTP 1.2
    Intervention: Other: CHTP 1.2
  • Active Comparator: CC
    Ad libitum use of subject's own preferred non-menthol brand of CC
    Intervention: Other: CC
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: September 29, 2016)
121
Original Estimated Enrollment  ICMJE
 (submitted: December 23, 2015)
120
Actual Study Completion Date  ICMJE July 2017
Actual Primary Completion Date August 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Subject is aged ≥ 28 years.
  • Subject is Caucasian.
  • Subject is healthy, as judged by the Investigator.
  • Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
  • Subject has smoked at least for the last 10 years.
  • Subject does not plan to quit smoking in the next 6 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 28 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 NCT02641587
Other Study ID Numbers  ICMJE P2R-REXA-07-EU
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: Monika Tomaszewska-Kiecana, MD BioVirtus Research Site
PRS Account Philip Morris Products S.A.
Verification Date March 2020

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