NCT05239884

CSD201202: A Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12

CSD201202: A Randomized, Crossover, Confinement Study to Assess Nicotine Uptake From Electronic Nicotine Delivery System P12

• 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 is an open-label, randomized, 8-way crossover study designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following an ad libitum use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in a confinement setting by generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS.

Detailed description

This study is designed to evaluate plasma nicotine pharmacokinetic (PK) parameters following the use of Electronic Nicotine Delivery System (ENDS) investigational products (IPs) in generally healthy combustible cigarette (CC) smokers and dual users of CC and ENDS. Potential subjects will complete a pre-screening interview and a Screening Visit to assess eligibility within 45 days prior to enrollment, randomization and confinement. Following the Screening Visit, eligible subjects will be scheduled for a check-in and randomization visit. At the check-in and randomization visit, subjects' continued eligibility will be confirmed prior to being randomized to a product use sequence and beginning 9 nights and 10 days of confinement. Starting on study Day 1, subjects will start a Pre-study ENDS IP Acclimation Period. During Pre-Study Product Acclimation Period, subjects will be required to acclimate to each of the ENDS IP at least once, while having access to their usual brand (UB) cigarettes for ad libitum use. Starting on Day 3, subjects will participate in eight separate Test Sessions for nicotine PK assessment, one for each ENDS IP. For approximately a half day prior to each respective Test Session (starting on Day 2), subjects will use the assigned ENDS IP for the following day's Test Session at least four times. Starting on Day 3 and continuing through Day 10, subjects will participate in eight separate Test Sessions, one for each IP that will last for approximately 4 hours following the start of 5 minutes of ad libitum IP use. During each Test Session, subjects will use one of the eight IPs. The ENDS IP for each Test Session will be determined based on a randomly assigned ENDS IP presentation schedule, where an 8-sequence ENDS IP use schedule will be generated using a Williams Design. Each Test Session will be preceded by a 12-hour tobacco/nicotine product abstention the night before.

Conditions

• Smoking
• Tobacco Use

Interventions

Type	Name	Description
OTHER	ENDS Product A with 1.5% nicotine	P1211216, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product B with 1.5% nicotine	P1213516, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product C with 1.5% nicotine	P1213416, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product D with 1.5% nicotine	P1212716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product E with 1.5% nicotine	P1213716, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product F with 1.5% nicotine	P1213816, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product G with 1.5% nicotine	P1211916, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine
OTHER	ENDS Product H with 1.5% nicotine	P1210016, an Electronic Nicotine Delivery System (ENDS) with 1.5% nicotine

Timeline

• Start date: 2022-03-14
• Primary completion: 2022-04-15
• Completion: 2022-04-15
• First posted: 2022-02-15
• Last updated: 2022-06-24

Locations

1 site across 1 country: United States