NCT04755348

A Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults

A Single Dose, Randomised, Crossover Study to Assess the Pharmacokinetics of Oral Nicotine Pouches and Lozenges in Healthy Adults

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: British American Tobacco (Investments) Limited · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomised, open-label, confined, cross-over study to evaluate the nicotine pharmacokinetics (PK) of modern oral nicotine pouches and nicotine lozenges carried out in 36 healthy adult subjects who smoke cigarettes and who may have experience using smokeless tobacco (loose or pouches).

Detailed description

Starting on Day 1, subjects will check-in at the clinical site to complete procedures to confirm eligibility. Following basic check-in procedures (e.g., urine pregnancy test, urine drug screen, alcohol test and vital signs), subjects will continue with a 7-day confinement. Subjects will be randomized to a product sequence (using a Williams design). Test sessions will occur every day during the remainder of the study. The active period of each test session will last for approximately 4 hours after the start of Investigational Product (IP) use. During each test session, a subject will be required to use their randomized IP and during the session, PK blood draws and a subjective effects questionnaire will be collected. The day prior to each test session, subjects will participate in a product familiarization period in which they will use one pouch or lozenge of their randomized IP. The product familiarization period will occur after the scheduled test session (or after enrollment and randomization on Day 1) and before the 12-hour tobacco and nicotine abstinence period. Subjects should use the IP pouch for at least 30 minutes or allow the lozenge to dissolve slowly. Subjects will provide usual brand (UB) cigarettes for use during study confinement and have access to their UB cigarettes for ad libitum use with the exception of 1) during the test session, 2) during the the minimum 12-hour tobacco and nicotine abstinence period prior to each test session and 3) a minimum of one hour after IP use during the product familiarization period. Each UB cigarette must be requested from site staff and used butts returned to site staff for accountability.

Conditions

• Tobacco Use
• Tobacco Smoking
• Cigarette Smoking

Interventions

Type	Name	Description
OTHER	Product A	A 4mg nicotine pouch product
OTHER	Product B	A 4mg nicotine pouch product
OTHER	Product C	A 2mg nicotine lozenge product
OTHER	Product D	A 2mg nicotine lozenge product
OTHER	Product E	A 2mg nicotine lozenge product
OTHER	Product F	A 2mg nicotine lozenge product

Timeline

• Start date: 2021-02-18
• Primary completion: 2021-03-20
• Completion: 2021-03-25
• First posted: 2021-02-16
• Last updated: 2021-03-30

Locations

1 site across 1 country: United States