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

Study Overview
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Brief Summary
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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.

Official Title
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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.

Conditions
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Smoking

Intervention / Treatment
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* Other: CHTP 1.0
* Other: Conventional Cigarette (CC)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CHTP 1.0<br>Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement | Other: CHTP 1.0<br>* CHTP 1.0 ad libitum for 5 days in confinement<br>|
| Active Comparator: Conventional cigarette (CC)<br>Ad libitum use of subject's own preferred brand of CC for 5 days in confinement | Other: Conventional Cigarette (CC)<br>* Subject's own preferred brand of CC ad libitum for 5 days in confinement<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares (LS) means are provided as descriptive statistics. | 5 days | 
| Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | 5 days | 
| Concentration of S-phenylmercapturic Acid (S-PMA) | Concentrations measured on Day 5 in urine, adjusted for creatinine. Geometric Least Squares means are provided as descriptive statistics. | 5 days | 
| Levels of Carboxyhemoglobin (COHb) | % 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. | 5 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Smoking, Modified risk tobacco product, Conventional cigarette, Reduced exposure, Confinement, Carbon Heated Tobacco Product