NCT06170138

Study to Assess PK, PD, Nicotine Extraction, Palatability, Subjective Effects of Nicotine Pouches - Daily Nicotine Users

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.

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 12 (estimated)
• Sponsor: Amplicon AB · Industry
• Sex: All
• Age: 25 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Nicotine Use Disorder

Interventions

Type	Name	Description
OTHER	Test product 1 - Test product 2 - Comparator product	Each subject will be randomised to 1 of 6 IP use sequences The IPs will be administered as single pouches in a pre-determined randomised order. Test product 1 - Ampli-01 3 mg, nicotine pouch Test product 2 - Ampli-01 6 mg, nicotine pouch Comparator product - ZYN Cool Mint Mini Dry 6 mg nicotine /pouch Single 30-minutes IP use on 3 occasions (Visits 2 to 4).

Timeline

• Start date: 2023-11-24
• Primary completion: 2023-12-14
• Completion: 2024-03-01
• First posted: 2023-12-14
• Last updated: 2023-12-14

Locations

1 site across 1 country: Sweden