NicotineNCT07135648
Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of VM 1.0 Compared to Cigarettes in Adult Current Smokers
A study testing VM16, VM32 and Cigarette (CC) in people with Nicotine, run by Philip Morris Products S.A. at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Nicotine
- What is being tested?
- VM16, VM32 and Cigarette (CC)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 17 Jul 2025to 6 Oct 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
- Participant or one of their family members is a current or former employee of the tobacco industry.
- Participant or one of their family members is an employee of the investigational site or of any other parties involved in the study.
- Participant has participated in another clinical study within 30 days prior to the Screening visit or concomitantly participates in any other investigational study.
- Participant has been previously screened or enrolled in this study (except alternates)
- For female participants only: participant has a positive urine pregnancy test at the Screening visit or at Admission or is a breastfeeding.
- For females of childbearing potential only: participant does not agree to use an acceptable method of effective contraception.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Controlled, Partially Blinded, Crossover Study to Evaluate the Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of Vibrating Mesh 1.0 (VM 1.0), a Nicotine-containing Aerosol Generator, Compared to Cigarettes in Adult Current Smokers
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
- Being tested
- VM16, VM32, Cigarette (CC)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VM16Other
VM16 contains a liquid with a nicotine concentration of 1.6%
VM32Other
VM32 contains a liquid with a nicotine concentration of 3.2%
Cigarette (CC)Other
Subjects will provide their own usual brand of commercially available cigarettes
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: Other: VM16; Other: VM32; Other: Cigarette (CC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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]
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 5 minutes prior to product use to 12 hours after product use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start17 Jul 2025
- Primary completion28 Jul 2025
- Study completion6 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for NicotineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Xavier Jaumont, MD, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07135648
- Sponsor's protocol ID
- NS-VM-PK-01
- Status last verified
- Aug 2025
- First submitted
- 14 Aug 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Controlled, Partially Blinded, Crossover Study to Evaluate the Nicotine Pharmacokinetics and Pharmacodynamics of Two Variants of Vibrating Mesh 1.0 (VM 1.0), a Nicotine-containing Aerosol Generator, Compared to Cigarettes in Adult Current Smokers
- ClinicalTrials.gov ID
- NCT07135648
- Acronym / sponsor ID
- NS-VM-PK-01
- Conditions
- Nicotine
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 17 Jul 2025 (actual)
- Primary completion
- 28 Jul 2025 (actual)
- Study completion
- 6 Oct 2025 (estimated)
- First posted
- 22 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Product Sequence 1 | Active comparator | Other: VM16, Other: VM32, Other: Cigarette (CC)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 |
| Product Sequence 2 | Active comparator | Other: VM16, Other: VM32, Other: Cigarette (CC)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 |
| Product Sequence 3 | Active comparator | Other: VM16, Other: VM32, Other: Cigarette (CC)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 |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (21 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VM16VM16 contains a liquid with a nicotine concentration of 1.6% | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3 |
| VM32VM32 contains a liquid with a nicotine concentration of 3.2% | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3 |
| Cigarette (CC)Subjects will provide their own usual brand of commercially available cigarettes | Other | Product Sequence 1, Product Sequence 2, Product Sequence 3 |
Primary outcome
Nicotine concentration
Time frame: From 5 minutes prior to product use to 12 hours after product use
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.
Maximum nicotine concentration
Time frame: From 5 minutes prior to product use to 12 hours after product use
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.
Area under the observed plasma nicotine concentration-time curve (AUC)
Time frame: From 5 minutes prior to product use to 12 hours after product use
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]
Time to the observed maximum concentration [Tmax]
Time frame: From 5 minutes prior to product use to 12 hours after product use
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.
Elimination rate constant [kel]
Time frame: From 5 minutes prior to product use to 12 hours after product use
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.
Half-life of nicotine [t1/2]
Time frame: From 5 minutes prior to product use to 12 hours after product use
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xavier Jaumont, MD study chair
Philip Morris Products S.A.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VM16, VM32 and Cigarette (CC) in people with Nicotine, run by Philip Morris Products S.A. at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Nicotine concentration (time frame: From 5 minutes prior to product use to 12 hours after product use). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Aug 2025.