Smoking BehaviorsPhase 1NCT07476144
Nicotine Pouch Pharmacokinetics Abuse Liability
A Phase 1 study testing Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. in people with Smoking Behaviors, run by JT International SA at 2 sites in United States.
Trial summary
Nicotine pharmacokinetics and subjective effects of Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design. Read more about this study
- Who is it for?
- Ages 22 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Smoking Behaviors
- What is being tested?
- Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Jan 2026to Oct 2026
- Phase
- Phase 1
- 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 22 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Voluntary consent to participate in this study documented on the signed ICF.
- Healthy adult males and females ≥22 and ≤65 years of age, at screening.
- Smokers and smokers that use other tobacco products (i.e., snus, moist snuff, Electronic Nicotine Delivery Systems, NP) will be considered. Smoking history (self-reported at screening) of an average of at least 5 but no more than 30 factory-manufactured combustible cigarettes daily for at least 12 months prior to screening. Brief periods (i.e., up to 7 consecutive days) of nonsmoking during the 3 months prior to screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
- Participants must demonstrate the ability to use a 12-mg NP for 30 minutes.
- Participants who use THC, must be willing to abstain from THC use for 7 days before Check-in and able to participate in the study without THC use.
- Participants must be generally healthy, free of lifetime malignant tumors, and without clinically significant abnormalities as assessed by the Investigator based on the review of medical and surgical history, physical examination, vital signs, 12-lead ECG, and laboratory evaluations conducted at screening and Check-in, as applicable. A single repeat measurement/test may be performed to confirm vital signs, 12-lead ECG, and clinical laboratory tests abnormalities (i.e.,to confirm that a participant is eligible).
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- Screening and first Check-in blood pressure ≤150/90 mmHg measured after being in the supine position or in the most recumbent position possible for at least 5 minutes. Two rechecks may be performed at the Principal Investigator's discretion.
- Positive urine cotinine (≥200 ng/mL) at screening.
- Exhaled carbon monoxide ≥8 ppm at screening.
- Male participants, if not surgically sterilized, must agree to use adequate contraception and not donate sperm from first Check-in (Day -1) to the clinical site until 90 days after the last administration of study product. Adequate contraception for the male participant (and his female partner, if she is of childbearing potential) is defined as using hormonal contraceptives or an intrauterine device combined with at least 1 of the following forms of contraception: a diaphragm, a cervical cap, or a condom. Total abstinence from heterosexual intercourse, in accordance with the lifestyle of the subject, is also acceptable.
- Negative pregnancy test at screening and first Check-in (Day -1) for all female participants.
- Female participants who are heterosexually active and of childbearing potential (e.g., neither surgically sterile at least 6 months prior to first Check-in nor postmenopausal with amenorrhea for at least 12 months prior to first Check-in with FSH levels consistent with postmenopausal status) must have been using one of the following forms of contraception for the time period indicated and agree to continue using it through completion of the study:
- Hormonal (e.g., oral, vaginal ring, transdermal patch, implant, injection) consistently for at least 3 months prior to first Check-in, when used in combination with male condoms with spermicide (use of NuvaRing is at the Principal Investigator's discretion)
- Double barrier (e.g., condom with spermicide or diaphragm with spermicide) consistently for at least 2 weeks prior to first Check-in
- Intrauterine device or system (utilize Principal Investigator discretion regarding use of hormonal or nonhormonal devices) for at least 3 months prior to first Check-in
- Exclusive partner who is clinically sterile (i.e., documented infertility or surgical sterilization; see below for additional information on sterility) or has been vasectomized for at least 6 months (inclusive) prior to first Check-in
- Note: Sexual abstinence, defined as refraining from intercourse, is allowed when this is in line with the preferred and usual lifestyle of the participant. Female participants of childbearing potential who are not currently engaging in heterosexual intercourse must agree to use one of the above methods of birth control through completion of study, in the event that they have heterosexual intercourse during the course of the study.
- Female participants who are of nonchildbearing potential must have undergone one of the following sterilization procedures at least 6 months prior to first Check-in:
- Hysteroscopic sterilization (including Essure or similar nonsurgical sterilization procedures)
- Bilateral tubal ligation or bilateral salpingectomy
- Hysterectomy
- Bilateral oophorectomy
- Or be postmenopausal with amenorrhea for at least 12 months prior to first Check-in and have FSH levels consistent with postmenopausal status.
- Able to communicate effectively with the study personnel and willing to comply with the requirements of the study.
- Willing and able to use all of the study products in-confinement and product use sessions
Who cannot join
- Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
- Any postponement of a quit attempt to participate in the study; or any attempts to quit smoking in the 3 months prior to Check-in).
- Poor dentition that prevents participant from using nicotine gum.
- History or presence of any type of malignant tumor or clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would interfere with the absorption, distribution, metabolism, or excretion of nicotine or jeopardize the safety of the participant or impact the validity of the study results.
- Current evidence or any history of congestive heart failure.
- Any other condition or prior therapy that, in the Investigator's opinion, would make the participant unsuitable for the study, or unable or unwilling to comply with the study procedures.
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- All prescribed medication must have been stopped at least 14 days prior to (first) admission to the clinical site. An exception is made for hormonal contraceptives that may be used throughout the study.
- All over-the-counter medication, vitamin preparations and other food supplements, or herbal medications (eg, St. John's wort) must have been stopped at least 14 days prior to (first) admission to the clinical site. An exception is made for acetaminophen that is allowed up to admission to the clinical site.
- Clinically significant abnormal vital sign, physical examination (including oral cavity and oropharynx), medical history, or clinical laboratory finding(s), in the opinion of the Investigator.
- Positive test for HIV-1 or HIV-2; or HBsAg or HCV consistent with current infection at screening.
- Diabetes mellitus that is not controlled by diet/exercise alone, in the opinion of the Investigator. Fasting plasma glucose >126 mg/dL (7 mmol/L) is exclusionary. One recheck may be performed for fasting plasma glucose values >126 mg/dL but <200 mg/dL.
- An acute illness (e.g., upper respiratory infection, viral infection) requiring treatment with prescribed medicines within 2 weeks prior to Check-in.
- History of surgery or major trauma within 12 weeks of screening, or surgery planned during the study through EOS.
- History of alcohol abuse or drug abuse within 24 months prior to Check-in.
- Consumption of alcohol-containing food or beverages within 48 hours prior to Check-in.
- Positive screen for alcohol (breath or urine) or drugs of abuse (urine), regardless of the reason of use at screening or Check-in, with the exception of positive results for THC. If positive for THC at check-in (Day -1), a cannabis intoxication evaluation will be performed, and inclusion will be at the discretion of the Investigator.
- Fever (i.e., body temperature >100.5°F) at screening or Check-in; 1 recheck may be performed at the Investigator's discretion.
- BMI <18.0 kg/m2 or >40.0 kg/m2 at screening.
- Estimated glomerular filtration rate <80 mL/minute using the CKD-EPI formula (Medscape) at screening.
- Serum alanine aminotransferase ≥1.5 times the upper limit of normal and/or aspartate aminotransferase ≥2.0 times the upper limit of normal at screening; 1 recheck may be performed at the Investigator's discretion.
- Female participants who are pregnant (positive pregnancy test at screening or Check-in), lactating, or intend to become pregnant from screening through EOS.
- Use of prescription or OTC bronchodilator medication (e.g., inhaled or oral β-agonists) for treatment of any illness within 12 months prior to Check-in.
- Use of antibiotics within 2 weeks prior to Check-in.
- Use of medications known or suspected to interact with cytochrome P450 2A6 (including, but not limited to, amiodarone, amlodipine, amobarbital, buprenorphine, clofibrate, clotrimazole, desipramine, disulfiram, entacapone, fenofibrate, isoniazid, ketoconazole, letrozole, methimazole, methoxsalen, metyrapone, miconazole, modafinil, orphenadrine, pentobarbital, phenobarbital, pilocarpine, primidone, propoxyphene, quinidine, rifampicin, rifampin, secobarbital, selegiline, sulconazole, and tioconazole, tranylcypromine) within 14 days or 5 half lives of the medication, whichever is longer, prior to Check-in.
- Has taken other investigational drugs/products or participated in any clinical study for an investigational drug, device, biologic, or for a tobacco product within 30 days or 5 half-lives (if known) of the investigational product's PK, PD, or biological activity (if known), whichever is longer, prior to first administration of study product in this study or is currently participating in another clinical study prior to Check-in.
- Has received a vaccination within 14 days prior to Check-in.
- Plasma donation within 7 days prior to Day 1.
- Donation of ≥1 unit of blood or blood products (with the exception of plasma as noted), had significant blood loss >450 mL, or received whole blood or a blood product transfusion within 56 days prior to Check-in.
- Strenuous activity (as assessed by the Investigator) within 48 hours prior to Check-in.
- Participant or a first-degree relative (i.e., parent, sibling, child, spouse) is a current or former employee of the tobacco industry, or a named party or class representative in litigation with any tobacco company.
- Participant or a first-degree relative (i.e., parent, sibling, child, spouse) is a current employee of the study site or service provider.
- Unwilling or unlikely to comply with the requirements of the study
Trial locations and contacts
2 sites in 1 country.
United States2 sites
AMR
Knoxville, Tennessee, 37920
ICON San Antonio
San Antonio, Texas, 78209
About this study
Official title: Nicotine Pharmacokinetics and Subjective Effects of 9 Investigational Nicotine Pouch Products in Adult Cigarette Smokers: A Controlled, Randomized, Cross-over Study With a Balanced Incomplete Block Design.
Nicotine pharmacokinetics and subjective effects of Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
Read the detailed description
To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Investigational nicotine pouches (NPs) relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product.
- Conditions
- Smoking Behaviors
- Being tested
- Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
- Medical subject headings
- Smoking
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.Drug
Also called Nicotine Pouch
Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. The pouch is not to be swallowed, chewed or broken. At the end of the 30-minute period, participants will remove the pouch and the study staff will collect and dispose of it accordingly.
Nicotine pouches deliver nicotine through the mucous membranes of the mouth.
| Study group | Role | What they receive |
|---|---|---|
| Nicotine Pouch Investigational Product (Test Product A) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product B) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product(Test Product C) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product D) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product E) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product F) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product G) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product H) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product I) | Experimental | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch (In-category Comparator Product) | Active comparator | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicorette 4 mg Mint Nicotine Gum (Reference Product) | Other | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Combustible Cigarette participant's usual brand (Reference Product) | Other | Not described Receives: Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigational Product nicotine pharmacokinetics and abuse liability
The purpose of this study is to acquire scientific data related to nicotine PK and abuse liability NPs:Nicotine uptake levels.
- Compare the abuse liability of Investigational products to UBCC, NRT and a NP comparator
- Safety data in humans This study will characterize the plasma nicotine PK, subjective effects, and PD (heart rate and blood pressure) of IP's compared to UBCC, NRT, and an NP comparator.
The subjective effects measures chosen for this study are standard measures to evaluate tobacco products:
- VAS measures of Assessment of Product Liking, Intent-to-Use-Again, Product Direct Effect, and Urge to Smoke questionnaires.
- 7-point Likert scale for the Product Evaluation Scale.
Measured: Screening: Between Day -28 and Day -1 (Check-in) Assessment period: 1 assessment period at the clinical site from Day-1 (check in) to Day 6 Early Termination: At the time of early termination
Characterize nicotine PK Parameters.
To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Investigational nicotine pouches (NPs) products relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product. AUC0-180: Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero to 180 minutes
Measured: Screening: Between Day -28 and Day -1 (Check-in) Assessment period: 1 assessment period at the clinical site from Day-1 (check in) to Day 6 Early Termination: At the time of early termination
Secondary outcomes (1)
Changes in heart rate and Blood Pressure
To assess changes in heart rate and blood pressure following the use of Investigational NP Products relative to UBCC, NRT gum, and a comparator NP.
Measured: Heart rate and blood pressure assessments measured during the start of test product use at -15 minutes, 10 minutes, 20 minutes, 40 minutes, 60 minutes at check-in and prior to the first PK sample of each day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2026
- Study start8 Jan 2026
- Primary completion31 Jul 2026
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Smoking BehaviorsStudies 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 1
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 55 participants (estimated)
Sponsor and investigators
- Lead sponsor
- JT International SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07476144
- Sponsor's protocol ID
- JTI-RS-25-09-NP_PK_AL
- Status last verified
- Aug 2026
- First submitted
- 9 Feb 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nicotine Pharmacokinetics and Subjective Effects of 9 Investigational Nicotine Pouch Products in Adult Cigarette Smokers: A Controlled, Randomized, Cross-over Study With a Balanced Incomplete Block Design.
- ClinicalTrials.gov ID
- NCT07476144
- Acronym / sponsor ID
- JTI-RS-25-09-NP_PK_AL
- Conditions
- Smoking Behaviors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 55 participants (estimated)
- Lead sponsor
- JT International SAIndustry (pharma, biotech, devices)
- Collaborators
- ICON Clinical Research
- Study start
- 8 Jan 2026 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- Oct 2026 (estimated)
- First posted
- 17 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.
Nicotine pharmacokinetics and subjective effects of Investigational Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.
Detailed description
To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Investigational nicotine pouches (NPs) relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 12
| Arm | Type | Receives |
|---|---|---|
| Nicotine Pouch Investigational Product (Test Product A) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product B) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product(Test Product C) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product D) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product E) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product F) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product G) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product H) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch Investigational Product (Test Product I) | Experimental | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicotine Pouch (In-category Comparator Product) | Active comparator | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Nicorette 4 mg Mint Nicotine Gum (Reference Product) | Other | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
| Combustible Cigarette participant's usual brand (Reference Product) | Other | Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. |
Who may qualify
- Ages
- 22 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (25 listed)
- Voluntary consent to participate in this study documented on the signed ICF.
- Healthy adult males and females ≥22 and ≤65 years of age, at screening.
- Smokers and smokers that use other tobacco products (i.e., snus, moist snuff, Electronic Nicotine Delivery Systems, NP) will be considered. Smoking history (self-reported at screening) of an average of at least 5 but no more than 30 factory-manufactured combustible cigarettes daily for at least 12 months prior to screening. Brief periods (i.e., up to 7 consecutive days) of nonsmoking during the 3 months prior to screening (e.g., due to illness or participation in a study where smoking was prohibited) will be permitted.
- Participants must demonstrate the ability to use a 12-mg NP for 30 minutes.
- Participants who use THC, must be willing to abstain from THC use for 7 days before Check-in and able to participate in the study without THC use.
Key exclusion criteria (32 listed)
- Self-reported puffers (i.e., adult smokers who draw smoke from the cigarette into the mouth and throat but do not inhale).
- Any postponement of a quit attempt to participate in the study; or any attempts to quit smoking in the 3 months prior to Check-in).
- Poor dentition that prevents participant from using nicotine gum.
- History or presence of any type of malignant tumor or clinically significant gastrointestinal, renal, hepatic, neurologic, hematologic, endocrine, oncologic, urologic, pulmonary, immunologic, psychiatric, or cardiovascular disease, or any other condition that, in the opinion of the Investigator, would interfere with the absorption, distribution, metabolism, or excretion of nicotine or jeopardize the safety of the participant or impact the validity of the study results.
- Current evidence or any history of congestive heart failure.
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 |
|---|---|---|
| Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.Also: Nicotine PouchParticipants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. The pouch is not to be swallowed, chewed or broken. At the end of the 30-minute period, participants will remove the pouch and the study staff will collect and dispose of it accordingly. Nicotine pouches deliver nicotine through the mucous membranes of the mouth. | Drug | Combustible Cigarette participant's usual brand (Reference Product), Nicorette 4 mg Mint Nicotine Gum (Reference Product), Nicotine Pouch (In-category Comparator Product), Nicotine Pouch Investigational Product (Test Product A), Nicotine Pouch Investigational Product (Test Product B), Nicotine Pouch Investigational Product (Test Product D), Nicotine Pouch Investigational Product (Test Product E), Nicotine Pouch Investigational Product (Test Product F), Nicotine Pouch Investigational Product (Test Product G), Nicotine Pouch Investigational Product (Test Product H), Nicotine Pouch Investigational Product (Test Product I), Nicotine Pouch Investigational Product(Test Product C) |
Primary outcome
Investigational Product nicotine pharmacokinetics and abuse liability
Time frame: Screening: Between Day -28 and Day -1 (Check-in) Assessment period: 1 assessment period at the clinical site from Day-1 (check in) to Day 6 Early Termination: At the time of early termination
The purpose of this study is to acquire scientific data related to nicotine PK and abuse liability NPs:Nicotine uptake levels. * Compare the abuse liability of Investigational products to UBCC, NRT and a NP comparator * Safety data in humans This study will characterize the plasma nicotine PK, subjective effects, and PD (heart rate and blood pressure) of IP's compared to UBCC, NRT, and an NP comparator. The subjective effects measures chosen for this study are standard measures to evaluate tobacco products: * VAS measures of Assessment of Product Liking, Intent-to-Use-Again, Product Direct Effect, and Urge to Smoke questionnaires. * 7-point Likert scale for the Product Evaluation Scale.
Characterize nicotine PK Parameters.
Time frame: Screening: Between Day -28 and Day -1 (Check-in) Assessment period: 1 assessment period at the clinical site from Day-1 (check in) to Day 6 Early Termination: At the time of early termination
To characterize nicotine pharmacokinetic (PK) parameters following a single ad libitum administration of 9 Investigational nicotine pouches (NPs) products relative to usual brand combustible cigarette (UBCC), Nicorette (NRT) gum, and a comparator NP product. AUC0-180: Area under the nicotine concentration-time curve calculated using linear trapezoidal summation from time zero to 180 minutes
1 secondary outcome
Changes in heart rate and Blood Pressure
Time frame: Heart rate and blood pressure assessments measured during the start of test product use at -15 minutes, 10 minutes, 20 minutes, 40 minutes, 60 minutes at check-in and prior to the first PK sample of each day.
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 19 Aug 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. in people with Smoking Behaviors, run by JT International SA at 2 sites in United States.
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 25 inclusion and 32 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 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Investigational Product nicotine pharmacokinetics and abuse liability (time frame: Screening: Between Day -28 and Day -1 (Check-in) Assessment period: 1 assessment period at the clinical site from Day-1 (check in) to Day 6 Early Termination: At the time of early termination). The study lists 2 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 19 Aug 2026.