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NCT04430634 · ClinicalTrials.gov registry record · NA

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

A NA study, sponsored by Fontem US.

Completed
Registry status
NA
Development phase
40
Enrollment target

NCT04430634: Completed NA study, sponsored by Fontem US.

NCT04430634 is a NA study that has completed, run by Fontem US. The registered enrollment target is 40 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04430634, a NA study, has completed, sponsored by Fontem US.

COMPLETED
Registry status
NA
Development phase
40 participants
Enrollment target

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)

Interventions

  • OTHER Myblu variant A
  • OTHER Myblu variant B
  • OTHER Myblu variant C
  • OTHER Myblu variant D
  • OTHER Myblu variant E

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2019-11-01
Est. Completion 2020-01-31
Phase NA
Fontem US

3 total trials

What the finished NCT04430634 record still lists

NCT04430634 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).

The record links to 0 conditions, and to 5 interventions - of which Myblu variant A is the first listed.

NCT04430634 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT04430634 about?

NCT04430634 is a clinical study titled "A Study to Evaluate Nicotine Uptake and Biomarkers in 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 NCT04430634?

This trial is currently completed. It is a NA study. The enrollment target is 40 participants. The study started on 2019-11-01. Estimated completion is 2020-01-31.

What interventions are being tested in trial NCT04430634?

The interventions under investigation include: Myblu variant A (OTHER), Myblu variant B (OTHER), Myblu variant C (OTHER), Myblu variant D (OTHER), Myblu variant E (OTHER).

Who is sponsoring clinical trial NCT04430634?

This trial is sponsored by Fontem US, which has 3 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT04430634's enrollment target sits among peer trials

40 1447th of 2000 higher than 465 of 2,000 other NA trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other NA 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04430634, the US trial registry maintained by the National Library of Medicine. NCT04430634 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.