A Study to Characterize Nicotine Pharmacokinetics and Subjective Effects of Nicotine Pouches in Adult Cigarette Smokers

Summary

Participation Requirements

Description

Potential subjects will complete screening procedures to assess their eligibility within 45 days prior to enrollment, randomization and confinement. Following the Screening Visit, eligible subjects will be scheduled for a Day 1 Check-in visit to complete procedures to confirm eligibility. Eligible s...

Potential subjects will complete screening procedures to assess their eligibility within 45 days prior to enrollment, randomization and confinement. Following the Screening Visit, eligible subjects will be scheduled for a Day 1 Check-in visit to complete procedures to confirm eligibility. Eligible subjects will be enrolled and begin confinement at the clinical site for 10 days and 9 nights. In addition, on Day 1, subjects will use at least one nicotine pouch (7 mg nicotine) but no more than 3 pouches to familiarize themselves with the investigational product (IP). Subjects will participate in separate Test Sessions for plasma nicotine PK assessment, one for each IP. Each Test Session will last for approximately 3 hours following the start of the IP use, and will include collection of plasma samples for PK assessments prior to, during, and following IP use. Safety will be monitored throughout the study by the Principal Investigator (PI) (or designee) by assessing adverse events (AEs), vital sign measurements, physical examinations (including an oral examination), and clinical laboratory tests. Mandatory physical and oral examination will be performed as part of end of study or early termination procedures. The clinical site will attempt to contact all subjects who used at least one IP (including subjects who terminate the study early) using their standard procedures approximately 7 days after the last IP use to determine if any AE has occurred since the last study visit. A return visit may be scheduled for follow-up assessments at the discretion of the PI or an appropriately qualified designee.

Tracking Information