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

Smoking Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02503254
• Other study ID #: P2R-REXC-06-EU
• Secondary ID: P2R-REXC-06-EU
• Status: Completed
• Phase: N/A
• Start date: July 2015
• Est. completion date: March 2016

Study information

• Verified date: January 2023
• Source: Philip Morris Products S.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 85
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Smoking

Intervention

Other:
• CHTP 1.0
CHTP 1.0 ad libitum for 5 days in confinement
• Conventional Cigarette (CC)
Subject's own preferred brand of CC ad libitum for 5 days in confinement

Locations

Country	Name	City	State
Poland	BioVirtus Research Site Sp. z o.o.	Kajetany

Sponsors (1)

Lead Sponsor	Collaborator
Philip Morris Products S.A.

Country where clinical trial is conducted

Poland, 

References & Publications (1)

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):19 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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