An Explorative, Open-label, Randomised, 3-way Cross-over Study to Assess the Pharmacokinetics, Pharmacodynamics, Nicotine Extraction, Palatability, and Subjective Effects After Single Use of Nicotine Pouches in Daily Nicotine Users.

Amplicon AB1 site in 1 country12 target enrollmentNovember 24, 2023

ConditionsNicotine Use Disorder

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Nicotine Use Disorder
Sponsor: Amplicon AB
Enrollment: 12
Locations: 1
Primary Endpoint: Terminal elimination half-life (T1/2)
Status: Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This is an explorative, open-label, randomised, 3-way cross-over study to assess pharmacokinetics (PK), pharmacodynamics (PD), safety and tolerability, nicotine extraction, palatability and subjective effects after single use of nicotine pouches in daily nicotine users.

Detailed Description

This is an explorative, open-label, randomised, 3-way cross-over, single use study, designed to assess the nicotine exposure from new nicotine pouch products. A cross-over design was chosen to yield a more efficient comparison of the IPs than a parallel study design, i.e., fewer subjects are required since each subject will serve as its own control. To avoid carryover effects, subjects will abstain from oral tobacco/nicotine products as well as smoking (cigarettes or e-cigarettes) for at least 12 hours prior to each IP use (Visit 2-4). Randomisation will be used to minimise bias in the assignment of subjects to an IP administration sequence and to increase the likelihood that known and unknown subject attributes (e.g., demographic and baseline characteristics) are evenly balanced. The main purpose of this study is to understand the PK as well as to analyse the nicotine content left in pouch after use of Ampli01 and compare with a reference product. This will give consumers a better understanding of the behaviour of the product with the aim to be a potential satisfactory alternative to cigarette smoking. In addition, the safety profile, PD and subjective effects will be investigated and evaluated. In summary, this study will provide critical data to assess PK, safety and formulation optimization to be able to provide consumers with a high-quality product. In addition, this study will contribute to the overall knowledge about nicotine pouches that can be of scientific value to improve public health strategies and regulations. The study will include 12 randomised and evaluable subjects. The subjects are healthy male or female oral tobacco/nicotine pouch users aged 25 to 55 years, inclusive, who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches (pouch strength 3-9 mg/pouch). Each subject will participate in the study for up to approximately 6 weeks, including the up to 28-day screening period.

Registry

clinicaltrials.gov

Start Date

November 24, 2023

End Date

March 2024

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Amplicon AB

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Willing and able to give written informed consent for participation in the study.
•Subjects who have used oral tobacco/nicotine products for ≥1 year, with a minimum daily consumption of 5 or more pouches with a pouch strength of 3-9 mg nicotine/pouch. Concomitant occasional use of other nicotine products (e.g., smoking, vaping) is allowed, as judged by the Investigator at the time of the screening visit.
•Healthy male or female subject aged 25 to 55 years, inclusive, at the time of the screening visit.
•Female subjects of childbearing potential must be willing to use a sufficient contraceptive method for the duration of the study, this includes mechanical barrier (e.g., a male condom or a female diaphragm), combined \[oestrogen and progestogen containing\] hormonal contraception associated with inhibition of ovulation \[oral, intravaginal, transdermal\], progestogen-only hormonal anticonception associated with inhibition of ovulation \[oral, injectable, implantable\], intra uterine device (IUD) or intra uterine system (IUS). Sexual abstinence is allowed when this is the preferred and usual lifestyle of the subject.
•Body Mass Index (BMI) ≥ 18.5 and ≤ 32.0 kg/m2 and a minimum weight of ≥ 50 kg.
•Medically healthy subject without abnormal clinically significant medical history, physical findings, vital signs, ECG and laboratory values at the time of the screening visit, as judged by the Investigator.
•Positive urine cotinine test (≥200 ng/mL) at the screening visit.

Exclusion Criteria

•History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the subject at risk because of participation in the study, or influence the results or the subject's ability to participate in the study.
•After 10 minutes supine rest at the screening visit, any vital signs values outside the following ranges: - Systolic blood pressure: \<90 or \>140 mmHg, or - Diastolic blood pressure \<50 or \>90 mmHg, or - Pulse \<40 or \>90 bpm
•Any surgical or medical condition, including abnormal salivation (also pharmaceutically induced), or history thereof, which, in the judgment of the Investigator, might interfere with the absorption, distribution, metabolism or excretion of the IP or may either put the subject at risk because of participation in the study, influence the results, or the subject's ability to participate in the study.
•A history of diagnosed severe allergy/hypersensitivity or ongoing manifestations of severe allergy/hypersensitivity to aroma compounds (including fragrances and/or flavourings), as judged by the Investigator.
•Any planned major surgery within the duration of the study.
•Subjects who are pregnant, currently breastfeeding, or intend to become pregnant during the course of the study.
•Any positive result at the screening visit for serum hepatitis B surface antigen, hepatitis C antibodies and/or HIV.
•Positive screening result for drugs of abuse or alcohol at the screening visit or on admission to the study site prior to IP use at Visits 2 to
•(Positive results that are expected given the subject's medical history and prescribed medications can be disregarded as judged by the Investigator.)
•Presence or history of drug abuse, as judged by the Investigator.