NCT05081154

CSD201002: Study to Assess Nicotine Uptake From P10 Nicotine Pouches

An In-Clinic Confinement Study to Assess Nicotine Uptake From P10 Nicotine Pouches

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: RAI Services Company · Industry
• Sex: All
• Age: 21 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study is a single-center, open-label, randomized, 7-way crossover study designed to evaluate plasma nicotine pharmacokinetics (PK) parameters following use of the study investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers.

Detailed description

This study is designed to evaluate plasma nicotine PK parameters following the use of nicotine pouches (hereinafter referred to as Velo Pouch IPs) in cigarette smokers and smokers who also use smokeless tobacco (SST) \[e.g., snus, moist snuff\]. At least one-third of the study population will include smokers who also use ST. Potential subjects may complete a pre-screening telephone interview. They will complete a Screening Visit 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 8 days and 7 nights. Subjects will participate in separate Test Sessions for plasma nicotine PK assessment, one for each IP. The IP for each Test Session will be determined based on a randomly assigned IP presentation schedule (14 product sequence) generated using a Williams Design. Each Test Session will last for approximately 4 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 and completion of the Overall Product Liking questionnaire. Subjects will use their randomized study IP one day before the respective test session to familiarize themselves with the IP.

Conditions

• Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	Product A	P1012915, a nicotine pouch with 8 mg nicotine
OTHER	Product B	P1013018, a nicotine pouch with 10 mg nicotine
OTHER	Product C	P1013015, a nicotine pouch with 8 mg nicotine
OTHER	Product D	P1012815, a nicotine pouch with 8 mg nicotine
OTHER	Product E	P1013315, a nicotine pouch with 8 mg nicotine
OTHER	Product F	P1013115, a nicotine pouch with 8 mg nicotine
OTHER	Product G	P1013215, a nicotine pouch with 8 mg nicotine

Timeline

• Start date: 2021-10-20
• Primary completion: 2021-11-24
• Completion: 2021-11-24
• First posted: 2021-10-18
• Last updated: 2022-06-27

Locations

1 site across 1 country: United States