Clinical trial NCT02641587: Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.
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 1.2 (CHTP 1.2), Compared to Continuing to Use Combustible Cigarettes, for 5 Days in Confinement Followed by 85 Days in an Ambulatory Setting.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Smoking
Keywords: Smoking
Cigarettes
Reduced exposure
Confinement
Ambulatory
Carbon Heated Tobacco Product
Lead sponsor: Philip Morris Products S.A.
Sponsor class: INDUSTRY
First posted: 2015-12-29
Enrollment: 121
Sex: ALL
Minimum age (years): 28
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: The overall goal of the study is to demonstrate reduction in the levels of biomarkers of exposure (BoExp) to selected harmful and potentially harmful constituents (HPHCs) identified in cigarettes and to obtain safety information in healthy adult smokers switching to the Carbon Heated Tobacco Product 1.2 (CHTP 1.2) as compared to subjects continuing smoking cigarettes (CC) in a confinement setting for 5 days (exclusive use) followed by an ambulatory setting of 85 days.


Eligibility criteria: Inclusion Criteria:

* Subject is aged ≥ 28 years.
* Subject is Caucasian.
* Subject is healthy, as judged by the Investigator.
* Subject has smoked at least 10 commercially available non-menthol CCs per day (no brand restrictions) at least for the last 6 weeks prior to the screening visit and admission.
* Subject has smoked at least for the last 10 years.
* Subject does not plan to quit smoking in the next 6 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.

Primary outcomes:
measure: Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)
timeFrame: 5 days
measure: Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)
timeFrame: 5 days
measure: Concentration of S-phenylmercapturic Acid (S-PMA)
timeFrame: 5 days
measure: Levels of Carboxyhemoglobin (COHb)
timeFrame: 5 days
measure: Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Nadarzyn
country: Poland
facility: BioVirtus Research Site Sp. z o.o.
Study officials:
affiliation: Philip Morris Products S.A.
name: Christelle Haziza, PhD
role: STUDY_CHAIR
affiliation: BioVirtus Research Site
name: Monika Tomaszewska-Kiecana, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bosilkovska M, Tran CT, de La Bourdonnaye G, Taranu B, Benzimra M, Haziza C. Exposure to harmful and potentially harmful constituents decreased in smokers switching to Carbon-Heated Tobacco Product. Toxicol Lett. 2020 May 5;330:30-40. doi: 10.1016/j.toxlet.2020.04.013. Online ahead of print.