NicotineNCT07459712
Pharmacokinetics and Pharmacodynamics of THS With LEVIA Compared to THS With TEREA and to Cigarettes
A study testing THS with LEVIA (ad libitum), THS with TEREA (ad libitum) and THS with LEVIA in people with Nicotine, run by Philip Morris Products S.A. at 1 site in Poland.
Trial summary
A single-center, randomized, controlled, open-label, crossover study in currently smoking adult participants to investigate the nicotine pharmacokinetics and pharmacodynamics of Tobacco Heating System (THS) with LEVIA, a tobacco-free nicotine-containing consumable, compared to THS with TEREA, a tobacco-containing… 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?
- THS with LEVIA (ad libitum), THS with TEREA (ad libitum) and THS with LEVIA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 sitePoland
- Study dates
- 1 Feb 2026to 14 Apr 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
- Male or female current (past 30 days) daily users of heated tobacco products and concomitantly smoking cigarettes aged between 21 and 65 years inclusive.
- Participant has used heated tobacco products (no brand restriction) for at least the last 6 months prior to the Screening visit.
- 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 used at least 10 heated tobacco products and/or commercially available cigarettes without any brand restriction or roll-your own cigarettes per day in the past 30 days prior to Screening visit and Admission.
- Participant has a urinary cotinine concentration of ≥ 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, prisoner).
- Participant has a health condition that requires medication or any other clinically relevant finding based on the assessment from the Screening visit (e.g., safety laboratory, 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 previously attempted to quit using tobacco- or nicotine-containing products within 28 days prior to the first investigational product use.
- Participant has donated plasma within seven days prior to the Screening visit or has donated or lost 450 mL or more of whole blood within 8 weeks prior to the Screening visit for males, and in the 12 weeks prior to the Screening visit for females.
- Participant has a known sensitivity or allergy to LEVIA or TEREA investigational products.
- 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 the Screening visit 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 screen test. The Principal Investigator will assess whether THC-positive participants are eligible for study participation.
- 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 a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to investigational product use, the administration of a biological product in the context of a clinical research study within 90 days prior to the Screening visit, or concomitant participation in an investigational study involving no drug or device administration.
- Participant has been previously screened or enrolled in this study (except overenrolled participants).
- For women only: participant with positive urine pregnancy tests at the Screening visit or at Admission, or is a lactating female.
- For women of childbearing potential only: participant does not agree to use an acceptable method of effective contraception throughout study participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Single-center, Randomized, Controlled, Openlabel, Cross-over Study in Currently Smoking Adult Participants to Investigate the Nicotine Pharmacokinetics and Pharmacodynamics of Tobacco Heating System (THS) With LEVIA, a Tobacco-free Nicotine-containing Product Compared to THS With TEREA, a Heated Tobacco Product and to Cigarettes
A single-center, randomized, controlled, open-label, crossover study in currently smoking adult participants to investigate the nicotine pharmacokinetics and pharmacodynamics of Tobacco Heating System (THS) with LEVIA, a tobacco-free nicotine-containing consumable, compared to THS with TEREA, a tobacco-containing consumable, and cigarettes.
The study will use a 2-period, 2-sequence design for the ad libitum use days, and a 3-period, 6-sequence Williams design for the single-use days. Across the ad libitum use and single-use period, this is a design with 5 periods and 12 sequences.
- Conditions
- Nicotine
- Being tested
- THS with LEVIA (ad libitum), THS with TEREA (ad libitum), THS with LEVIA, THS with TEREA, Cigarette
- Keywords
- Heated Tobacco
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
THS with LEVIA (ad libitum)Other
On Day 1 through Day 2, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use THS with LEVIA ad libitum in the randomized product-use sequence. The ad libitum use period will last approximately 12 hours.
THS with TEREA (ad libitum)Other
On Day 1 through Day 2, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use THS with TEREA ad libitum in the randomized product-use sequence. The ad libitum use period will last approximately 12 hours.
THS with LEVIAOther
On Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use a single THS with LEVIA in the randomized product-use sequence, as instructed by the investigational site staff.
THS with TEREAOther
On Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use a single THS with TEREA in the randomized product-use sequence, as instructed by the investigational site staff.
CigaretteOther
On Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use their usual brand of cigarettes according to the randomized product-use sequence and as instructed by the investigational site staff.
| Study group | Role | What they receive |
|---|---|---|
| Ad libitum product use (day 1; day 2) | Active comparator | Participants will be simultaneously randomized to product use sequences for ad libitum use.
The list of possible sequences are:
* THS with LEVIA; THS with TEREA
* THS with TEREA; THS with LEVIA Receives: Other: THS with LEVIA (ad libitum); Other: THS with TEREA (ad libitum) |
| Single product use (day 3; day 4; day 5) | Active comparator | Participants will be simultaneously randomized to product use sequences for single product use.
The list of possible sequences are:
* Cigarette; THS with LEVIA; THS with TEREA
* Cigarette; THS with TEREA; THS with LEVIA
* THS with LEVIA; Cigarette; THS with TEREA
* THS with LEVIA; THS with TEREA; Cigarette
* THS with TEREA; Cigarette; THS with LEVIA
* THS with TEREA; THS with LEVIA; Cigarette Receives: Other: THS with LEVIA; Other: THS with TEREA; Other: Cigarette |
What is being measured
The primary outcome is the main question the study is designed to answer.
Background-corrected plasma nicotine concentrations (cC0h) to (cC12h)
To measure the background-corrected plasma nicotine concentrations (cC0h) to (cC12h)
Measured: Measured from Day 3 to Day 5
Background-corrected maximum plasma nicotine concentration (Cmax)
To measure the background-corrected maximum plasma nicotine concentration [Cmax]
Measured: Measured from Day 3 to Day 5
Area under the background-corrected plasma nicotine concentration-time curve (AUC) (AUC) from the start of product use (T0) to the timepoint of last quantifiable concentration (AUC0-last) and extrapolated to infinity (AUC0-infinity)
To measure the area under the background-corrected plasma nicotine concentration-time curve (AUC)
Measured: Measured from Day 3 to Day 5
Time to the background-corrected maximum concentration (Tmax)
To measure the time to the background-corrected maximum concentration [Tmax]
Measured: Measured from Day 3 to Day 5
Terminal elimination rate constant (λz)
To measure the terminal elimination rate constant (λz)
Measured: Measured from Day 3 to Day 5
Half-life of nicotine (t1/2)
To measure the half-life of nicotine (t1/2)
Measured: Measured from Day 3 to Day 5
Secondary outcomes (7)
Product consumption
Product consumption expressed as number of LEVIA or TEREA sticks (N sticks)
Measured: Measured from Day 1 to Day 2
NEQ in Plasma
Nicotine, cotinine and trans-3'-hydroxycotinine concentrations expressed as nicotine equivalents in plasma (NEQplasma)
Measured: Measured from Day 1 to Day 2
NEQ in Urine
Nicotine and metabolites concentrations expressed as nicotine equivalents adjusted to creatinine (NEQcreate) in first void urine
Measured: Measured from Day 1 to Day 3
Craving for using a tobacco or nicotine product
Craving will be self-reported on a Visual Analogue Scale, asking participants to rate their craving for using a tobacco or nicotine product on a 100 mm unipolar scale, ranging from 0 (no craving) to 100 (strong craving).
Measured: Measured from Day 3 to Day 5
Product Liking
Product liking will be self-reported on a Visual Analogue Scale, stating "Overall, my liking for this product is:" which participants will complete on a 100 mm bipolar scale, ranging from 0 (strong disliking) to 100 (strong liking) with a neutral middle point.
Measured: Measured from Day 3 to Day 5
Nicotine Satisfaction
Satisfaction with the perceived nicotine content will be self-reported on a Visual Analogue Scale, stating "Overall, the nicotine level in this product is:" which participants will complete on a 100 mm bipolar scale, ranging from 0 (not enough) to 100 (too much) with a middle point (just right).
Measured: Measured from Day 3 to Day 5
Product Experience
The 12-item self-report measure consists of three multi-item scales and two single-item scales:
- Aversion (e.g., dizziness, nausea),
- Craving reduction, Enjoyment of sensation in the mouth (single-item assessment),
- Product satisfaction (e.g., satisfying, tastes good), and
- Psychological rewards (e.g., helps concentrate, reduces hunger).
Participants rate each item on a 7-point scale, ranging from 1 (not at all) to 7 (extremely).
A score is computed for each of the five scales. For each scale, the mean of the individual item responses is calculated. Higher scores indicate higher perceived intensity of the effect.
Measured: Measured from Day 3 to Day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2026
- Study start1 Feb 2026
- Primary completion9 Feb 2026
- Study completion14 Apr 2026
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
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Philip Morris Products S.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Christelle Haziza, PhD, Study chair, Philip Morris Products S.A.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07459712
- Sponsor's protocol ID
- P1-LEV-PK-01
- Status last verified
- May 2026
- First submitted
- 5 Mar 2026
- Last updated
- 5 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-center, Randomized, Controlled, Openlabel, Cross-over Study in Currently Smoking Adult Participants to Investigate the Nicotine Pharmacokinetics and Pharmacodynamics of Tobacco Heating System (THS) With LEVIA, a Tobacco-free Nicotine-containing Product Compared to THS With TEREA, a Heated Tobacco Product and to Cigarettes
- ClinicalTrials.gov ID
- NCT07459712
- Acronym / sponsor ID
- P1-LEV-PK-01
- Conditions
- Nicotine
- Keywords
- Heated Tobacco
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Philip Morris Products S.A.Industry (pharma, biotech, devices)
- Study start
- 1 Feb 2026 (actual)
- Primary completion
- 9 Feb 2026 (actual)
- Study completion
- 14 Apr 2026 (actual)
- First posted
- 10 Mar 2026 (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, open-label, crossover study in currently smoking adult participants to investigate the nicotine pharmacokinetics and pharmacodynamics of Tobacco Heating System (THS) with LEVIA, a tobacco-free nicotine-containing consumable, compared to THS with TEREA, a tobacco-containing consumable, and cigarettes.
The study will use a 2-period, 2-sequence design for the ad libitum use days, and a 3-period, 6-sequence Williams design for the single-use days. Across the ad libitum use and single-use period, this is a design with 5 periods and 12 sequences.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ad libitum product use (day 1; day 2) | Active comparator | Other: THS with LEVIA (ad libitum), Other: THS with TEREA (ad libitum)Participants will be simultaneously randomized to product use sequences for ad libitum use. The list of possible sequences are: * THS with LEVIA; THS with TEREA * THS with TEREA; THS with LEVIA |
| Single product use (day 3; day 4; day 5) | Active comparator | Other: THS with LEVIA, Other: THS with TEREA, Other: CigaretteParticipants will be simultaneously randomized to product use sequences for single product use. The list of possible sequences are: * Cigarette; THS with LEVIA; THS with TEREA * Cigarette; THS with TEREA; THS with LEVIA * THS with LEVIA; Cigarette; THS with TEREA * THS with LEVIA; THS with TEREA; Cigarette * THS with TEREA; Cigarette; THS with LEVIA * THS with TEREA; THS with LEVIA; Cigarette |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Participant has signed the Informed Consent Form (ICF) and is able to understand the information provided in the ICF.
- Male or female current (past 30 days) daily users of heated tobacco products and concomitantly smoking cigarettes aged between 21 and 65 years inclusive.
- Participant has used heated tobacco products (no brand restriction) for at least the last 6 months prior to the Screening visit.
- 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 used at least 10 heated tobacco products and/or commercially available cigarettes without any brand restriction or roll-your own cigarettes per day in the past 30 days prior to Screening visit and Admission.
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, prisoner).
- Participant has a health condition that requires medication or any other clinically relevant finding based on the assessment from the Screening visit (e.g., safety laboratory, 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 |
|---|---|---|
| THS with LEVIA (ad libitum)On Day 1 through Day 2, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use THS with LEVIA ad libitum in the randomized product-use sequence. The ad libitum use period will last approximately 12 hours. | Other | Ad libitum product use (day 1; day 2) |
| THS with TEREA (ad libitum)On Day 1 through Day 2, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use THS with TEREA ad libitum in the randomized product-use sequence. The ad libitum use period will last approximately 12 hours. | Other | Ad libitum product use (day 1; day 2) |
| THS with LEVIAOn Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use a single THS with LEVIA in the randomized product-use sequence, as instructed by the investigational site staff. | Other | Single product use (day 3; day 4; day 5) |
| THS with TEREAOn Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use a single THS with TEREA in the randomized product-use sequence, as instructed by the investigational site staff. | Other | Single product use (day 3; day 4; day 5) |
| CigaretteOn Day 3 through Day 5, after at least 10 hours of abstinence from any tobacco and nicotine-containing products, participants will use their usual brand of cigarettes according to the randomized product-use sequence and as instructed by the investigational site staff. | Other | Single product use (day 3; day 4; day 5) |
Primary outcome
Background-corrected plasma nicotine concentrations (cC0h) to (cC12h)
Time frame: Measured from Day 3 to Day 5
To measure the background-corrected plasma nicotine concentrations (cC0h) to (cC12h)
Background-corrected maximum plasma nicotine concentration (Cmax)
Time frame: Measured from Day 3 to Day 5
To measure the background-corrected maximum plasma nicotine concentration [Cmax]
Area under the background-corrected plasma nicotine concentration-time curve (AUC) (AUC) from the start of product use (T0) to the timepoint of last quantifiable concentration (AUC0-last) and extrapolated to infinity (AUC0-infinity)
Time frame: Measured from Day 3 to Day 5
To measure the area under the background-corrected plasma nicotine concentration-time curve (AUC)
Time to the background-corrected maximum concentration (Tmax)
Time frame: Measured from Day 3 to Day 5
To measure the time to the background-corrected maximum concentration [Tmax]
Terminal elimination rate constant (λz)
Time frame: Measured from Day 3 to Day 5
To measure the terminal elimination rate constant (λz)
Half-life of nicotine (t1/2)
Time frame: Measured from Day 3 to Day 5
To measure the half-life of nicotine (t1/2)
7 secondary outcomes
Product consumption
Time frame: Measured from Day 1 to Day 2
NEQ in Plasma
Time frame: Measured from Day 1 to Day 2
NEQ in Urine
Time frame: Measured from Day 1 to Day 3
Craving for using a tobacco or nicotine product
Time frame: Measured from Day 3 to Day 5
Product Liking
Time frame: Measured from Day 3 to Day 5
Nicotine Satisfaction
Time frame: Measured from Day 3 to Day 5
Product Experience
Time frame: Measured from Day 3 to Day 5
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
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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.
Christelle Haziza, PhD 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 THS with LEVIA (ad libitum), THS with TEREA (ad libitum) and THS with LEVIA in people with Nicotine, run by Philip Morris Products S.A. at 1 site in Poland.
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 8 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: finished, as of the sponsor's last update on 5 May 2026. 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 Poland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Background-corrected plasma nicotine concentrations (cC0h) to (cC12h) (time frame: Measured from Day 3 to Day 5). 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 5 May 2026.