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.

JT International SA2 sites in 1 country55 target enrollmentStarted: January 8, 2026Last updated: March 17, 2026

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

Overview

Phase: Phase 1
Status: Recruiting
Sponsor: JT International SA
Enrollment: 55
Locations: 2
Primary Endpoint: Nordic Spirit pouch nicotine pharmacokinetics and abuse liability

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

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.

Detailed Description

Study Design

Study Type: Interventional
Allocation: Randomized
Intervention Model: Crossover
Primary Purpose: Other
Masking: None

Eligibility Criteria

Ages: 22 Years to 65 Years (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: Yes

Inclusion Criteria

•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.

Exclusion Criteria

•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.