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

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.

Conditions

• Smoking
• Tobacco Use

Interventions

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

Sponsors & Collaborators

• RAI Services Company

  lead INDUSTRY

Principal Investigators

• Jason Hong, MD · RAIS

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

60 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2022-03-14

Primary Completion

2022-04-15

Completion

2022-04-15

Countries

• United States

Study Locations