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

Healthy Volunteers Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430634
• Other study ID #: CA22749
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: January 31, 2020

Study information

• Verified date: May 2021
• Source: Fontem Ventures BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: January 31, 2020
• Est. primary completion date: January 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 21 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Myblu variant A
Use of Myblu e-cigarette with flavor A 2.4% nicotine
• Myblu variant B
Use of Myblu e-cigarette with flavor B 3.6% nicotine
• Myblu variant C
Use of Myblu e-cigarette with flavor C 2.5% nicotine
• Myblu variant D
Use of Myblu e-cigarette with flavor D 4.0% nicotine
• Myblu variant E
Use of Myblu e-cigarette with flavor E 3.6% nicotine
• Myblu variant F
Use of Myblu e-cigarette with flavor F 2.4% nicotine
• Myblu variant G
Use of Myblu e-cigarette with flavor G 4.0% nicotine
• Myblu variant H
Use of Myblu e-cigarette with flavor H 3.6% nicotine

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (2)

Lead Sponsor	Collaborator
Fontem US LLC	Fontem Ventures BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum Nicotine Concentration in Blood	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)
Primary	Concentration of Carboxyhemoglobin in Blood	Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.	Baseline and 8 days
Primary	Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours	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
Primary	Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours	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
Primary	Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours	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	Level of White Blood Cells	The change from baseline in the level of white blood cells, a biomarker of potential harm.	Baseline and 8 days
Secondary	Spirometry: Forced Expiratory Volume in 1 Second	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
Secondary	Spirometry: Forced Vital Capacity	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
Secondary	Subjective Measure: Urge to Smoke	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