A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes

Summary

This study evaluates the overall performance of the currently-marketed MybluTM e-cigarette device and pods, as assessed by nicotine uptake, exposure to smoke constituents, safety and consumer satisfaction, over 8 days. The study is designed as an open-label, randomized study in adult smokers.

Subjects are invited to participate to a second part of the study, for 5 additional days, to compare the use of MybluTM to the use of subject's usual brand combustible cigarettes.

Conditions

• Healthy Volunteers

Interventions

OTHER

Myblu variant A

Use of Myblu e-cigarette with flavor A 2.4% nicotine

OTHER

Myblu variant B

Use of Myblu e-cigarette with flavor B 3.6% nicotine

OTHER

Myblu variant C

Use of Myblu e-cigarette with flavor C 2.5% nicotine

OTHER

Myblu variant D

Use of Myblu e-cigarette with flavor D 4.0% nicotine

OTHER

Myblu variant E

Use of Myblu e-cigarette with flavor E 3.6% nicotine

OTHER

Myblu variant F

Use of Myblu e-cigarette with flavor F 2.4% nicotine

OTHER

Myblu variant G

Use of Myblu e-cigarette with flavor G 4.0% nicotine

OTHER

Myblu variant H

Use of Myblu e-cigarette with flavor H 3.6% nicotine

Sponsors & Collaborators

• Fontem Ventures BV

  collaborator INDUSTRY

• Fontem US LLC

  lead INDUSTRY

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Model

CROSSOVER

Eligibility

Min Age

21 Years

Max Age

65 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-11-01

Primary Completion

2020-01-31

Completion

2020-01-31

Countries

• United States

Study Locations