Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability

NCT07476144 | Recruiting Phase 1 FDA Drug

• 1 other identifier: JTI-RS-25-09-NP_PK_AL
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 2

Brief Summary

Nicotine pharmacokinetics and subjective effects of 9 Nordic Spirit Nicotine Pouch Products in adult cigarette smokers: A controlled, randomized, cross-over study with a balanced incomplete block design.

Conditions

Smoking Behaviors

Outcome Measures

Primary Outcomes (2)

• Nordic Spirit pouch nicotine pharmacokinetics and abuse liability

  The purpose of this study is to acquire scientific data related to nicotine PK and abuse liability of Nordic Spirit NPs in support of a PMTA:Nicotine uptake levels following Nordic Spirit NP use * Compare the abuse liability of Nordic Spirit NPs 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 Nordic Spirit NPs 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.

  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 Nordic Spirit nicotine pouches (NPs) 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

  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

  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.

Study Arms (12)

Nordic Spirit Nicotine Pouch Dark Fizz (6 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Forest Berries (9 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Frosty Mint (9 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Frosty Mint (12 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Frosty Berry (12 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Raspberry (6 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Sweet Mint (3 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Sweet Mint (6 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

Nordic Spirit Nicotine Pouch Sweet Mint (9 mg nicotine/pouch) (Test Product)

EXPERIMENTAL

Drug: Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.

ZYN 6 mg Wintergreen 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 (menthol or nonmenthol), 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.

Interventions

Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions. DRUG

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.

Also known as: Nicotine Pouch

Combustible Cigarette (menthol or nonmenthol), participant's usual brand (Reference Product); Nicorette 4 mg Mint Nicotine Gum (Reference Product); Nordic Spirit Nicotine Pouch Dark Fizz (6 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Forest Berries (9 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Frosty Berry (12 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Frosty Mint (12 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Frosty Mint (9 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Raspberry (6 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Sweet Mint (3 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Sweet Mint (6 mg nicotine/pouch) (Test Product); Nordic Spirit Nicotine Pouch Sweet Mint (9 mg nicotine/pouch) (Test Product); ZYN 6 mg Wintergreen Nicotine Pouch (In-category Comparator Product)

Eligibility Criteria

• Age: 22 Years - 65 Years
• Gender Eligibility Details: Male and Female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• 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

You may not qualify if:

• 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.
• 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.
• 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.
• Fever (i.e., body temperature \>100.5°F) at screening or Check-in; 1 recheck may be performed at the Investigator's discretion.

Sponsors & Collaborators

• JT International SA: lead
• ICON Clinical Research: collaborator

Study Sites (2)

AMR

Knoxville, Tennessee, 37920, United States

RECRUITING

ICON San Antonio

San Antonio, Texas, 78209, United States

RECRUITING

MeSH Terms

Conditions

Smoking

Condition Hierarchy (Ancestors)

Behavior

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 9, 2026
• First Posted: March 17, 2026
• Study Start: January 8, 2026
• Primary Completion: April 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: March 17, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)