Reduced Exposure Study Using the CHTP 1.2 With 5 Days in a Confinement Setting Followed by 85 Days in an Ambulatory Setting.

NCT02641587 | Completed Results

• 1 other identifier: P2R-REXA-07-EU
• Study Type: interventional
• Target: 121
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking

Keywords

Smoking; Cigarettes; Reduced exposure; Confinement; Ambulatory; Carbon Heated Tobacco Product

Outcome Measures

Primary Outcomes (5)

• Concentrations of Monohydroxybutenylmercapturic Acid (MHBMA)

  Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

  5 days

• Concentration of 3-hydroxypropylmercapturic Acid (3-HPMA)

  Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

  5 days

• Concentration of S-phenylmercapturic Acid (S-PMA)

  Concentrations measured at Day 5 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

  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 (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 5 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

  5 days

• Concentrations of Total 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol (Total NNAL)

  Concentrations measured at Day 90 in urine, adjusted for creatinine. Geometric least squares (LS) means and confidence intervals (Cls) from a generalized linear model conducted on log-transformed Day 90 values with log-transformed baseline value, study arm, sex and CC consumption reported at admission as fixed effect factors.

  90 days

Study Arms (2)

CHTP 1.2

EXPERIMENTAL

Ad libitum use of the CHTP 1.2

Other: CHTP 1.2

CC

ACTIVE COMPARATOR

Ad libitum use of subject's own preferred non-menthol brand of CC

Other: CC

Interventions

CHTP 1.2 OTHER

Ad libitum use of the CHTP 1.2 for 5 days in confinement followed by 85 days in an ambulatory setting.

CHTP 1.2

CC OTHER

Ad libitum use of subject's own preferred non-menthol brand of CC for 5 days in confinement followed by 85 days in an ambulatory setting.

CC

Eligibility Criteria

• Age: 28 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

BioVirtus Research Site Sp. z o.o.

Nadarzyn, 05-830, Poland

Location

Related Publications (1)

• 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 Sep 15;330:30-40. doi: 10.1016/j.toxlet.2020.04.013. Epub 2020 May 5.

  PMID: 32380119 RESULT

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

• Title: Christelle Haziza
• Organization: Philip Morris Products S.A.

christelle.haziza@pmi.com

+41 58 242 11 11

Study Officials

• Christelle Haziza, PhD

  Philip Morris Products S.A.

  STUDY CHAIR

• Monika Tomaszewska-Kiecana, MD

  BioVirtus Research Site

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 23, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: July 1, 2017
• Last Updated: February 21, 2023
• Results First Posted: March 6, 2019

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PL (1)