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Completed

NCT Number: NCT04430634

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.

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.

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Key information

Conditions

Healthy Volunteers

Age range

21 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Celerion

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • smoking an average of at least 10 manufactured combustible cigarettes per day for at least 12 months prior to Screening
  • tested positive for urine cotinine (≥ 200 ng/mL) at Screening
  • exhaled carbon monoxide > 10 ppm (parts per million) at Screening

Exclusion criteria

  • relevant illness history
  • relevant medication use
  • body mass index (BMI) > 40 kg/m2 or < 18 kg/m2 at Screening
  • allergy to propylene glycol or glycerin
  • use of nicotine-containing products other than manufactured combustible cigarettes within 14 days prior to Check-in
  • use of any prescription smoking cessation treatments within 3 months prior to Check-in
  • smokers who draw smoke from the cigarette into the mouth and throat but do not inhale
  • planning to quit smoking during the study
  • female subjects who are pregnant, lactating, or intend to become pregnant

Treatment and study plan

Myblu variant A

Other

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

Myblu variant B

Other

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

Myblu variant C

Other

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

Myblu variant D

Other

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

Myblu variant E

Other

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

Myblu variant F

Other

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

Myblu variant G

Other

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

Myblu variant H

Other

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

Primary outcomes

  1. Maximum Nicotine Concentration in Blood

    Time frame: 180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)

    Maximum nicotine concentration in blood (Cmax)

  2. Concentration of Carboxyhemoglobin in Blood

    Time frame: Baseline and 8 days

    Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.

  3. Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours

    Time frame: Baseline and 8 days

    Change from baseline in the amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol (NNAL), a biomarker of exposure to 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanone (NNK), excreted in urine during 24 hours (creatinine adjusted).

  4. Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours

    Time frame: Baseline and 8 days

    Change from baseline in the amount of 3-hydroxypropylmercapturic acid (3-HPMA), a biomarker of exposure to acrolein, excreted in urine during 24 hours (creatinine adjusted).

  5. Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours

    Time frame: Baseline and 8 days

    Change from baseline in the amount of S-phenyl mercapturic acid (S-PMA), a biomarker of exposure to benzene, excreted in urine during 24 hours (creatinine adjusted).

Secondary outcomes

  1. Level of White Blood Cells

    Time frame: Baseline and 8 days

    The change from baseline in the level of white blood cells, a biomarker of potential harm.

  2. Spirometry: Forced Expiratory Volume in 1 Second

    Time frame: Baseline and 8 days

    Forced expiratory volume in 1 second (FEV1) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.

  3. Spirometry: Forced Vital Capacity

    Time frame: Baseline and 8 days

    Forced vital capacity (FVC) measurement conducted in accordance with the 2005 American Thoracic Society / European Respiratory Society Joint Task Force on the standardization of spirometry, with subject in a sitting position following at least 15 minutes of rest and at least 1 hour from the last product use.

  4. Subjective Measure: Urge to Smoke

    Time frame: 8 days

    Urge to smoke score: Subjects answer the following question "How strong is your urge to smoke right now?" using a visual analogue scale (VAS). The scale ranges from "Not at all", given a score of 0, to "Extremely", given a score of 100, after ad libitum use of the product.

Sponsors and collaborators

Lead sponsor

Fontem US LLC

Industry

Collaborators

  • Fontem Ventures BV

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 12, 2020
Registry last updated
Jun 7, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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