A Study to Evaluate Nicotine Uptake and Biomarkers in Adult 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 flavor A_2.4

Use of Myblu e-cigarette with flavor 1 at 2.4% nicotine

OTHER

Myblu flavor B_2.4

Use of Myblu e-cigarette with flavor 2 at 2.4% nicotine

OTHER

Myblu flavor C_2.4

Use of Myblu e-cigarette with flavor C at 2.4% nicotine

OTHER

Myblu flavor D_2.4

Use of Myblu e-cigarette with flavor D at 2.4% nicotine

OTHER

Myblu flavor E_1.2

Use of Myblu e-cigarette with flavor 1 at 1.2% nicotine

OTHER

Myblu flavor F_1.2

Fse of Myblu e-cigarette with flavor F at 1.2% nicotine

OTHER

Myblu flavor G_2.4

Use of Myblu e-cigarette with flavor G at 2.4% nicotine

OTHER

Myblu flavor H_2.4

Use of Myblu e-cigarette with flavor H at 2.4% 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

2019-12-01

Primary Completion

2020-01-31

Completion

2020-01-31

Countries

• United States

Study Locations