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

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.

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.

Study Overview

• Status: Completed
• Conditions: Smoking
• Intervention / Treatment: Other: CHTP 1.0; Other: Conventional Cigarette (CC)

• Study Type: Interventional
• Enrollment (Actual): 85
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Poland
  • Kajetany, Poland, 05-830
    • BioVirtus Research Site Sp. z o.o.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: Philip Morris Products S.A.
• Investigators: Principal Investigator: Katarzyna Jarus-Dziedzic, MD, PhD, Biovirtus Research Site

Publications and helpful links

General 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.

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): September 1, 2015
• Study Completion (Actual): March 1, 2016

Study Registration Dates

• First Submitted: July 17, 2015
• First Submitted That Met QC Criteria: July 17, 2015
• First Posted (Estimate): July 20, 2015

Study Record Updates

• Last Update Posted (Estimate): January 30, 2023
• Last Update Submitted That Met QC Criteria: January 26, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: Smoking; Confinement; Modified risk tobacco product; Conventional cigarette; Reduced exposure; Carbon Heated Tobacco Product
• Other Study ID Numbers: P2R-REXC-06-EU (Other Identifier: Philip Morris Products S.A.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No