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NCT04429932 · ClinicalTrials.gov registry record · NA
A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes
A NA study of Healthy Volunteers, sponsored by Fontem US.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
- 1
- Study location
NCT04429932: Completed NA study of Healthy Volunteers, sponsored by Fontem US.
NCT04429932 is a NA study of Healthy Volunteers that has completed, run by Fontem US. The registered enrollment target is 39 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04429932, a NA study of Healthy Volunteers, has completed, sponsored by Fontem US.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
Maximum nicotine concentration in blood (Cmax)
Conditions Studied
Interventions
- OTHER Myblu flavor A_2.4
- OTHER Myblu flavor B_2.4
- OTHER Myblu flavor C_2.4
- OTHER Myblu flavor D_2.4
- OTHER Myblu flavor E_1.2
Study Locations (1)
Nebraska
- Celerion - Lincoln
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2019-12-01 |
| Est. Completion | 2020-01-31 |
| Phase | NA |
What the finished NCT04429932 record still lists
NCT04429932 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (92% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 5 interventions - of which Myblu flavor A_2.4 is the first listed.
NCT04429932 reports a single indexed study location in Nebraska.
Frequently Asked Questions
What is clinical trial NCT04429932 about?
NCT04429932 is a clinical study titled "A Study to Evaluate Nicotine Uptake and Biomarkers in Adult Smokers Using mybluTM Electronic Cigarettes". 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. Subje...
What is the current status of trial NCT04429932?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2019-12-01. Estimated completion is 2020-01-31.
What conditions does trial NCT04429932 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT04429932?
The interventions under investigation include: Myblu flavor A_2.4 (OTHER), Myblu flavor B_2.4 (OTHER), Myblu flavor C_2.4 (OTHER), Myblu flavor D_2.4 (OTHER), Myblu flavor E_1.2 (OTHER).
Who is sponsoring clinical trial NCT04429932?
This trial is sponsored by Fontem US, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04429932 being conducted?
This trial has 1 study location across Nebraska. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04429932's enrollment target sits among peer trials
39 161st of 283 higher than 121 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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