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

• 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: Philip Morris Products S.A.
• Information provided by (Responsible Party): Philip Morris Products S.A.

Tracking Information

• First Submitted Date: July 17, 2015
• First Posted Date: July 20, 2015
• Results First Submitted Date: November 4, 2016
• Results First Posted Date: March 10, 2017
• Last Update Posted Date: January 30, 2023
• Study Start Date: July 2015
• Actual Primary Completion Date: September 2015 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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

• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Reduced Exposure Study Using CHTP 1.0 During 5 Days in Confinement.
• 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.
• 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Other
• Condition: Smoking

Intervention

• 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

• 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.

Recruitment Information

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

Eligibility 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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 21 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Poland

Administrative Information

• NCT Number: NCT02503254
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Philip Morris Products S.A.
• Original Responsible Party: Same as current
• Current Study Sponsor: Philip Morris Products S.A.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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