Reduced HPHC Exposure in Cigarette Smokers Switching to P4M3 Gen. 2.0 Compared to Continuing Smoking, or Smoking Abstinence

Sponsor

Philip Morris Products S.A. (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05487456

Collaborator

(none)

Enrollment

Location

Arms

3.6

Anticipated Duration (Months)

20.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To demonstrate the reduction of Biomarkers of Exposure (BoExp) to selected harmful and potentially harmful constituents (HPHC) in smokers switching from cigarette (CIG) to P4M3, an Electronic Nicotine Delivery System (ENDS), compared to continuing cigarette smoking for 5 days.

Condition or Disease	Intervention/Treatment	Phase
Nicotine Vaping Nicotine Vaping	Other: P4M3 CA35 Other: P4M3 CM35 Other: CIG Other: Smoking Abstinence	N/A

Detailed Description

This clinical study aims to demonstrate the reduction of BoExp to selected HPHC in smokers switching from CIG to two flavor variants of P4M3 as compared to smokers continuing smoking CIG, or to smoking abstinence (SA).

A reduction of exposure to HPHC from CIG smoke is expected to diminish the health risk of nicotine consumption if switching completely to ENDS.

The data collected in this study in confinement will provide information on exposure reductions achievable in a well-controlled environment with full control on daily P4M3/CIG consumption and compared to SA.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

72 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Other

Official Title:

A Randomized, Controlled, Open-label, 4-arm Parallel Group Study to Demonstrate Reductions in Exposure to Selected Harmful and Potentially Harmful Constituents (HPHC) in Healthy Smokers Switching to 2 Variants of P4M3 Gen 2.0, an Electronic Nicotine Delivery System (ENDS), Compared to Continuing Smoking Cigarettes, or Abstaining From Smoking, for 5 Days in a Confinement Setting

Actual Study Start Date :

Jul 15, 2022

Anticipated Primary Completion Date :

Sep 2, 2022

Anticipated Study Completion Date :

Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: P4M3 CA35 Ad libitum use of P4M3 using CA35 Cartridges	Other: P4M3 CA35 Ad libitum use of P4M3 with CA35 cartridges Other Names: P4M3 "Classic Auburn" 3.5% nicotine (CA35)
Active Comparator: P4M3 CM35 Ad libitum use of P4M3 using CM35 Cartridges	Other: P4M3 CM35 Ad libitum use of P4M3 with CM35 cartridges Other Names: P4M3 "Classic Menthol" 3.5% nicotine (CM35)
Active Comparator: Cigarette Ad libitum use of subject's own preferred CIG brand	Other: CIG Ad libitum use of subject's own preferred brand of cigarettes Other Names: Cigarette
Active Comparator: Smoking Abstinence Smoking abstinence	Other: Smoking Abstinence Abstention from cigarette smoking

Outcome Measures

Primary Outcome Measures

3-HPMA [From baseline to 5 days]
To measure change in 3-hydroxypropyl mercapturic acid (3-HPMA), which is a biomarker of exposure to Acrolein.
2-CyEMA [From baseline to 5 days]
To measure change in 2-cyanoethyl mercapturic acid (2-CyEMA), which is a biomarker of exposure to Acrylonitrile.
Total NNAL [From baseline to 5 days]
To measure change in Total 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (total NNAL), which is a biomarker of exposure to 4-(methylnitrosamino)-1-(3- pyridyl)-1-butanone (NNK).
COHb [From baseline to 5 days]
To measure change in carboxyhemoglobin (COHb), which is a biomarker of exposure to Carbon monoxide (CO).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Main Inclusion Criteria:

Subject has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
Subject has been a smoker for ≥3 years prior to the screening visit (smoking cessation attempts during this period, if any, did not last >6 months).
Subject has continuously smoked on average ≥10 commercially available mentholated or non-mentholated CIGs per day over the last 4 weeks prior to screening and admission. Smoking status will be verified based on a urinary cotinine test (cotinine ≥200 ng/mL).
Subject is healthy as judged by the Investigator based on available assessments from the screening period (e.g., safety laboratory, spirometry, vital signs, physical examination, ECG, and medical history).

Main Exclusion Criteria:

Subject has a clinically relevant disease which requires medication (including but not limited to gastrointestinal, renal, hepatic, neurological, hematological, endocrine, oncological, urological, immunological, pulmonary, and cardiovascular disease) or any other medical condition (including safety laboratory), which as per the judgment of the Investigator would jeopardize the safety of the subject.
Subject experienced within 30 days prior to screening/admission a body temperature

37.5°C or an acute illness (e.g., upper respiratory-tract infection, viral infection, etc.)

As per the Investigator's judgment, the subject has medical conditions which do or will require a medical intervention (e.g., start of treatment, surgery, hospitalization) during the study participation, which may interfere with the study participation and/or study results.
Subject has relevant history of a current asthma condition or chronic obstructive pulmonary disease (COPD) condition, and/or clinically significant spirometry findings at Screening or Baseline
Subject has donated blood or received whole blood or blood products within 3 months prior to screening.
BMI <18.5 kg/m2 or ≥32.0 kg/m2.