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 : January 30, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Smoking | Other: CHTP 1.0 Other: Conventional Cigarette (CC) | Not Applicable |
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 |
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
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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
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Other: Conventional Cigarette (CC)
Subject's own preferred brand of CC ad libitum for 5 days in confinement |
- 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.

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

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
Poland | |
BioVirtus Research Site Sp. z o.o. | |
Kajetany, Poland, 05-830 |
Study Chair: | Christelle Haziza, PhD | Philip Morris Products S.A. | |
Principal Investigator: | Katarzyna Jarus-Dziedzic, MD, PhD | BioVirtus Research Site |
Documents provided by Philip Morris Products S.A.:
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: | January 30, 2023 |
Last Verified: | January 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Smoking Modified risk tobacco product Conventional cigarette |
Reduced exposure Confinement Carbon Heated Tobacco Product |