Nordic Spirit Pouch Nicotine Pharmacokinetics Abuse Liability
ConditionSmoking Behaviors
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age22-65
SponsorJT International SA
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial design
Design model
Crossover
Treatments tested in this trial
Participants will place the pouch between their top lip and their gum for 30 minutes as per use instructions.
DrugParticipants 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.
Treatment groups
55 Participants
are divided into 12 treatment groups12
Treatment groupsSee each treatment group below.
Group A: Nordic Spirit Nicotine Pouch Dark Fizz (6 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group B: Nordic Spirit Nicotine Pouch Forest Berries (9 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group C: Nordic Spirit Nicotine Pouch Frosty Mint (9 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group D: Nordic Spirit Nicotine Pouch Frosty Mint (12 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group E: Nordic Spirit Nicotine Pouch Frosty Berry (12 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group F: Nordic Spirit Nicotine Pouch Raspberry (6 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group G: Nordic Spirit Nicotine Pouch Sweet Mint (3 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group H: Nordic Spirit Nicotine Pouch Sweet Mint (6 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group I: Nordic Spirit Nicotine Pouch Sweet Mint (9 mg nicotine/pouch) (Test Product)Experimental treatment 1 intervention
Group J: ZYN 6 mg Wintergreen Nicotine Pouch (In-category Comparator Product)Active comparator 1 intervention
Group K: Nicorette 4 mg Mint Nicotine Gum (Reference Product)Other 1 intervention
Group L: Combustible Cigarette (menthol or nonmenthol), participant's usual brand (Reference Product)Other 1 intervention
Trial outcomes
Primary outcomes
1
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.
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 termination2
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
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 terminationSecondary outcomes
1
Changes in heart rate and Blood Pressure
To assess changes in heart rate and blood pressure following the use of Nordic Spirit NP relative to UBCC, NRT gum, and a comparator NP (ZYN Wintergreen).
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
JT International SA
Lead sponsor
ICON Clinical Research
Collaborator
Source ClinicalTrials.gov