CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
Myblu variant A +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/NCT04430634
NCT04430634N/ACompleted
CompareCT.gov

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 variant A, Myblu variant B, and 6 other interventions for Healthy Volunteers. Completed, enrolled 40 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--
ConditionsHealthy Volunteers
CountriesUnited States
CollaboratorsFontem Ventures BV

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJun 12, 2020
Enrollment StartNov 1, 2019
Primary CompletionJan 31, 2020
TodayJul 2, 2026
Enrollment to primary: 3 monthsPosted 6.1 years ago

Interventions

Myblu variant Aother

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

Myblu variant Bother

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

Myblu variant Cother

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

Myblu variant Dother

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

Myblu variant Eother

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

Myblu variant Fother

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

Myblu variant Gother

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

Myblu variant Hother

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