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

NCT05487456 | Completed Results

• 1 other identifier: P4-REXC-06
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Nicotine; Vaping; Nicotine Vaping

Keywords

Nicotine; Smoking; Cigarette; E-Cigarette; Electronic Nicotine Delivery System; Vaping

Outcome Measures

Primary Outcomes (4)

• 3-HPMA

  To measure change in 3-hydroxypropyl mercapturic acid (3-HPMA), which is a biomarker of exposure to Acrolein.

  From baseline to 5 days

• 2-CyEMA

  To measure change in 2-cyanoethyl mercapturic acid (2-CyEMA), which is a biomarker of exposure to Acrylonitrile.

  From baseline to 5 days

• Total NNAL

  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).

  From baseline to 5 days

• COHb

  To measure change in carboxyhemoglobin (COHb), which is a biomarker of exposure to Carbon monoxide (CO).

  From baseline to 5 days

Study Arms (4)

P4M3 CA35

ACTIVE COMPARATOR

Ad libitum use of P4M3 using CA35 Cartridges

Other: P4M3 CA35

P4M3 CM35

ACTIVE COMPARATOR

Ad libitum use of P4M3 using CM35 Cartridges

Other: P4M3 CM35

Cigarette

ACTIVE COMPARATOR

Ad libitum use of subject's own preferred CIG brand

Other: CIG

Smoking Abstinence

ACTIVE COMPARATOR

Smoking abstinence

Other: Smoking Abstinence

Interventions

P4M3 CA35 OTHER

Ad libitum use of P4M3 with CA35 cartridges

Also known as: P4M3 "Classic Auburn" 3.5% nicotine (CA35)

P4M3 CA35

P4M3 CM35 OTHER

Ad libitum use of P4M3 with CM35 cartridges

Also known as: P4M3 "Classic Menthol" 3.5% nicotine (CM35)

P4M3 CM35

CIG OTHER

Ad libitum use of subject's own preferred brand of cigarettes

Also known as: Cigarette

Cigarette

Smoking Abstinence OTHER

Abstention from cigarette smoking

Smoking Abstinence

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Celerion

Belfast, United Kingdom

Location

MeSH Terms

Conditions

Vaping; Smoking

Interventions

Nicotine; Tobacco Products

Condition Hierarchy (Ancestors)

Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring; Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: Christelle Haziza, Global Head Clinical Research and Execution
• Organization: Philip Morris Products S.A.

ClinicalTrials.PMI@pmi.com

+41 58 242 11 11

Study Officials

• Patrick Winiger, MD

  Celerion

  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: July 25, 2022
• First Posted: August 4, 2022
• Study Start: July 15, 2022
• Primary Completion: August 31, 2022
• Study Completion: November 7, 2022
• Last Updated: March 13, 2024
• Results First Posted: March 13, 2024

Record last verified: 2023-06

Locations

GB (1)