- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04430634
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
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
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 Overview
Status
Conditions
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Nebraska
-
Lincoln, Nebraska, United States, 68502
- Celerion
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: OTHER
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: ABDC
Subjects use MybluTM e-cigarette product variant A (2.4 % nicotine) ad libitum for 2 days, then switch to use variant B (3.6% nicotine) for 2 days, then D (4.0% nicotine) for 2 days and then C (2.5% nicotine) for 2 days.
A washout period of 12 hours product abstinence is observed between product variants.
For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
|
Use of Myblu e-cigarette with flavor A 2.4% nicotine
Use of Myblu e-cigarette with flavor B 3.6% nicotine
Use of Myblu e-cigarette with flavor C 2.5% nicotine
Use of Myblu e-cigarette with flavor D 4.0% nicotine
|
EXPERIMENTAL: BCAD
Same as previous arm, but in a different randomization order.
|
Use of Myblu e-cigarette with flavor A 2.4% nicotine
Use of Myblu e-cigarette with flavor B 3.6% nicotine
Use of Myblu e-cigarette with flavor C 2.5% nicotine
Use of Myblu e-cigarette with flavor D 4.0% nicotine
|
EXPERIMENTAL: CDBA
Same as previous arm, but in a different randomization order.
|
Use of Myblu e-cigarette with flavor A 2.4% nicotine
Use of Myblu e-cigarette with flavor B 3.6% nicotine
Use of Myblu e-cigarette with flavor C 2.5% nicotine
Use of Myblu e-cigarette with flavor D 4.0% nicotine
|
EXPERIMENTAL: DACB
Same as previous arm, but in a different randomization order.
|
Use of Myblu e-cigarette with flavor A 2.4% nicotine
Use of Myblu e-cigarette with flavor B 3.6% nicotine
Use of Myblu e-cigarette with flavor C 2.5% nicotine
Use of Myblu e-cigarette with flavor D 4.0% nicotine
|
EXPERIMENTAL: EFHG
Subjects use MybluTM e-cigarette product variant E (3.6 % nicotine) ad libitum for 2 days, then switch to use variant F (2.4% nicotine) for 2 days, then H (3.6% nicotine) for 2 days and then G (4.0% nicotine) for 2 days.
A washout period of 12 hours product abstinence is observed between product variants.
For each product variant, in the morning of the second product use day, a controlled product use session is performed (10 puffs taken at 30-second intervals, with puffs 3 seconds in duration).
|
Use of Myblu e-cigarette with flavor E 3.6% nicotine
Use of Myblu e-cigarette with flavor F 2.4% nicotine
Use of Myblu e-cigarette with flavor G 4.0% nicotine
Use of Myblu e-cigarette with flavor H 3.6% nicotine
|
EXPERIMENTAL: FGEH
Same as previous arm, but in a different randomization order.
|
Use of Myblu e-cigarette with flavor E 3.6% nicotine
Use of Myblu e-cigarette with flavor F 2.4% nicotine
Use of Myblu e-cigarette with flavor G 4.0% nicotine
Use of Myblu e-cigarette with flavor H 3.6% nicotine
|
EXPERIMENTAL: GHFE
Same as previous arm, but in a different randomization order.
|
Use of Myblu e-cigarette with flavor E 3.6% nicotine
Use of Myblu e-cigarette with flavor F 2.4% nicotine
Use of Myblu e-cigarette with flavor G 4.0% nicotine
Use of Myblu e-cigarette with flavor H 3.6% nicotine
|
EXPERIMENTAL: HEGF
Same as previous arm, but in a different randomization order.
|
Use of Myblu e-cigarette with flavor E 3.6% nicotine
Use of Myblu e-cigarette with flavor F 2.4% nicotine
Use of Myblu e-cigarette with flavor G 4.0% nicotine
Use of Myblu e-cigarette with flavor H 3.6% nicotine
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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)
|
180 minutes following the start of the controlled product use session on Day 2 (12 measurements over the period)
|
Concentration of Carboxyhemoglobin in Blood
Time Frame: Baseline and 8 days
|
Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
|
Baseline and 8 days
|
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).
|
Baseline and 8 days
|
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).
|
Baseline and 8 days
|
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).
|
Baseline and 8 days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
Baseline and 8 days
|
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.
|
Baseline and 8 days
|
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.
|
Baseline and 8 days
|
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.
|
8 days
|
Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- CA22749
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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