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

Not Applicable

Completed

• Conditions: Smoking
• Interventions: Other: Conventional Cigarette (CC); Other: CHTP 1.0

• Registration Number: NCT02503254
• Lead Sponsor: Philip Morris Products S.A.

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 available

Study Timeline

• Study Start: 2015-07
• Study First Submitted: 2015-07-17
• Study First Submitted QC: 2015-07-17
• Study First Posted: 2015-07-20
• Primary Completion: 2015-09
• Study Completion: 2016-03
• Results First Submitted: 2016-11-04
• Results First Submitted QC: 2017-01-19
• Results First Posted: 2017-03-10
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-26
• Last Update Posted: 2023-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 85

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Conventional cigarette (CC)	Conventional Cigarette (CC)	Ad libitum use of subject's own preferred brand of CC for 5 days in confinement
CHTP 1.0	CHTP 1.0	Ad libitum use of the Carbon Heated Tobacco Product 1.0 (CHTP 1.0) for 5 days in confinement

Primary Outcome Measures

Name	Time	Method
Levels of Carboxyhemoglobin (COHb)	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.
Concentration of Monohydroxybutenyl Mercapturic Acid (MHBMA)	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)	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)	5 days	Concentrations measured on Day 5 in urine, adjusted for creatinine.; Geometric Least Squares means are provided as descriptive statistics.

Trial Locations

Locations (1)

BioVirtus Research Site Sp. z o.o.; 🇵🇱 Kajetany, Poland