Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of VM 1.0 Compared to Cigarettes in Adult Current Smokers

NCT07135648 | Active Not Recruiting

• 1 other identifier: NS-VM-PK-01
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

A single-center, randomized, controlled, partially blinded, crossover study to evaluate the pharmacokinetics and pharmacodynamics of nicotine following use of two variants of VM 1.0, VM16 and VM32, a nicotine-containing aerosol generator compared to cigarettes in adult current smokers. The participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. The study will be conducted with 3 periods and 3 sequences.

Conditions

Nicotine

Outcome Measures

Primary Outcomes (6)

• Nicotine concentration

  To measure the observed plasma nicotine concentration \[C -5min\] and \[C 12hours\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.

  From 5 minutes prior to product use to 12 hours after product use

• Maximum nicotine concentration

  To measure the maximum observed plasma nicotine concentration \[Cmax\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.

  From 5 minutes prior to product use to 12 hours after product use

• Area under the observed plasma nicotine concentration-time curve (AUC)

  To measure the area under the observed plasma nicotine concentration-time curve (AUC) from the start the first puff (T0) to the timepoint of last quantifiable concentration \[AUC 0-last\] and extrapolated to infinity \[AUC 0-infinity\]

  From 5 minutes prior to product use to 12 hours after product use

• Time to the observed maximum concentration [Tmax]

  To measure the time to the observed maximum concentration \[Tmax\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.

  From 5 minutes prior to product use to 12 hours after product use

• Elimination rate constant [kel]

  To measure the elimination rate constant \[kel\]\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.

  From 5 minutes prior to product use to 12 hours after product use

• Half-life of nicotine [t1/2]

  To measure half-life of nicotine \[t1/2\], to describe the plasma concentration-time profile of nicotine and derived pharmacokinetic (PK) parameters from VM16 and VM32 use with a fixed puffing regimen and single cigarette smoking.

  From 5 minutes prior to product use to 12 hours after product use

Study Arms (3)

Product Sequence 1

ACTIVE COMPARATOR

On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette

Other: VM16; Other: VM32; Other: Cigarette (CC)

Product Sequence 2

ACTIVE COMPARATOR

On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette

Other: VM16; Other: VM32; Other: Cigarette (CC)

Product Sequence 3

ACTIVE COMPARATOR

On Day 1 to Day 3, after at least 10 hours of abstinence from any nicotine/tobacco containing products and after at least 10 hours of fasting, participants will use one of the three investigational products according to randomized product use sequence and as instructed by the investigational site personnel. The list of possible sequences are: Cigarette; VM32; VM16 / VM16; Cigarette; VM32 / VM32; VM16; Cigarette

Other: VM16; Other: VM32; Other: Cigarette (CC)

Interventions

VM16 OTHER

VM16 contains a liquid with a nicotine concentration of 1.6%

Product Sequence 1; Product Sequence 2; Product Sequence 3

VM32 OTHER

VM32 contains a liquid with a nicotine concentration of 3.2%

Product Sequence 1; Product Sequence 2; Product Sequence 3

Cigarette (CC) OTHER

Subjects will provide their own usual brand of commercially available cigarettes

Product Sequence 1; Product Sequence 2; Product Sequence 3

Eligibility Criteria

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

You may qualify if:

• Participant has signed the ICF and is able to understand the information provided in the ICF.
• Male or female participant between 21 and 65 years inclusive.
• Participant has smoked commercially available or roll-your own cigarettes (no brand restrictions) for at least the last 12 months prior to the Screening visit.
• Participant has smoked at least 10 commercially available cigarettes per day in the past 30 days prior to the Screening visit and Admission.
• Nicotine exposure status will be verified by urinary cotinine test (cotinine ≥ 200 ng/mL).
• Participant has a BMI \>18.5 and \<30.0 kg/m2 and body weight ≥50.0 kg for males and ≥45.0 kg for females.
• Participant is available for the entire study period and willing to comply with study procedures, including product use assignments and periods of abstinence from any nicotine/tobacco containing products and willing to adhere to a standardized diet.

You may not qualify if:

• Participant has reasons other than medical (e.g., psychological, social reason) not to be part of the study, as determined by the Principal Investigator or designee.
• Participant is legally incompetent, or physically or mentally incapable of giving consent (e.g., emergency situation, under guardianship, prisoners).
• Participant has a health condition which requires medication or any other clinically significant finding e.g., safety labs, pulmonary function test, vital signs, physical examination, ECG and medical history, as determined by the Principal Investigator or designee.
• Participant experiences difficulty with venipuncture and/or poor venous access.
• Participant has medical conditions which require, or will require during the study, a medical intervention (e.g., start of treatment, surgery, hospitalization).
• Presence of fever (body temperature \>37.5°C) e.g., a fever associated with a symptomatic viral or bacterial infection.
• Participant has a hemoglobin level \< 11.0 g/dL for females and \< 12.0 g/dL for males at the Screening visit.
• Participant uses medication that aids in smoking cessation.
• Participant uses Tetrahydrocannabinol (THC)-containing products.
• Participant previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to Admission.
• Participant has donated plasma within seven days prior to screening or has donated or lost 450 mL or more of whole blood within 8 weeks prior to Screening for males, and in the 12 weeks prior to the Screening visit for females.
• Participant has a positive serology test for HIV 1/2, hepatitis B or C.
• Participant has a medical history of alcohol abuse within one year prior to Screening or regular use of alcohol within six months prior to the Screening visit that exceeds 10 units for women or 15 units for men of alcohol per week.
• Participant has a positive urine drug test.
• Participant has a positive alcohol breath test.

Sponsors & Collaborators

• Philip Morris Products S.A.: lead

Study Sites (1)

Celerion

Belfast, BT9 6AD, United Kingdom

Location

MeSH Terms

Interventions

Tobacco Products

Intervention Hierarchy (Ancestors)

Smoking Devices; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Xavier Jaumont, MD

  Philip Morris Products S.A.

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a partially blinded study: the participants will be blinded to the variants of VM 1.0 and to the randomized product use sequences. As part of the PMP quality control (QC) activity, a blinded data review will be performed before database lock. Data listings will be reviewed by the CRO and PMP, with no access to the product information for data review team members. Full details will be available in the data review plan.
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Study Start: July 17, 2025
• Primary Completion: July 28, 2025
• Study Completion: October 6, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)