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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05487456
Recruitment Status : Completed
First Posted : August 4, 2022
Last Update Posted : January 26, 2023
Sponsor:
Information provided by (Responsible Party):
Philip Morris Products S.A.

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 Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 68 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 : July 15, 2022
Actual Primary Completion Date : September 2, 2022
Actual Study Completion Date : November 7, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: E-Cigarettes Smoking

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 Name: 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 Name: 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 Name: Cigarette

Active Comparator: Smoking Abstinence
Smoking abstinence
Other: Smoking Abstinence
Abstention from cigarette smoking




Primary Outcome Measures :
  1. 3-HPMA [ Time Frame: From baseline to 5 days ]
    To measure change in 3-hydroxypropyl mercapturic acid (3-HPMA), which is a biomarker of exposure to Acrolein.

  2. 2-CyEMA [ Time Frame: From baseline to 5 days ]
    To measure change in 2-cyanoethyl mercapturic acid (2-CyEMA), which is a biomarker of exposure to Acrylonitrile.

  3. Total NNAL [ Time Frame: 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).

  4. COHb [ Time Frame: From baseline to 5 days ]
    To measure change in carboxyhemoglobin (COHb), which is a biomarker of exposure to Carbon monoxide (CO).



Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05487456


Locations
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United Kingdom
Celerion
Belfast, United Kingdom
Sponsors and Collaborators
Philip Morris Products S.A.
Investigators
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Principal Investigator: Patrick Winiger, MD Celerion
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Responsible Party: Philip Morris Products S.A.
ClinicalTrials.gov Identifier: NCT05487456    
Other Study ID Numbers: P4-REXC-06
First Posted: August 4, 2022    Key Record Dates
Last Update Posted: January 26, 2023
Last Verified: January 2023

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Philip Morris Products S.A.:
Nicotine
Smoking
Cigarette
E-Cigarette
Electronic Nicotine Delivery System
Vaping
Additional relevant MeSH terms:
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Menthol
Nicotine
Ganglionic Stimulants
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Nicotinic Agonists
Cholinergic Agonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Antipruritics
Dermatologic Agents