CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 39 enrolled
Drug / intervention
Myblu flavor A_2.4 +7 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04429932
NCT04429932N/ACompleted

An Open-Label, Randomized, Crossover Study to Assess Nicotine Uptake, Tobacco-Related Biomarkers of Exposure, Biomarkers of Potential Harm, and Puff Topography With Use of mybluTM Electronic Cigarettes in Adult Smokers

Fontem US LLC·interventional·Posted Jun 12, 2020·Updated Jun 7, 2021

In Brief

A clinical study evaluating Myblu flavor A_2.4, Myblu flavor B_2.4, and 6 other interventions for Healthy Volunteers. Completed, enrolled 39 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsFontem Ventures BV

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 12, 2020
Enrollment StartDec 1, 2019
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.1 years ago

Interventions

Myblu flavor A_2.4other

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

Myblu flavor B_2.4other

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

Myblu flavor C_2.4other

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

Myblu flavor D_2.4other

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

Myblu flavor E_1.2other

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

Myblu flavor F_1.2other

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

Myblu flavor G_2.4other

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

Myblu flavor H_2.4other

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