N/A
N=40
A Study to Evaluate Nicotine Uptake and Biomarkers in Smokers Using mybluTM Electronic Cigarettes
Healthy Volunteers
Bottom Line
View on ClinicalTrials.gov: NCT04430634 ↗Enrolled (actual)
40
Serious AEs
0.0%
Results posted
Jun 2021
Primary outcome: Primary: Maximum Nicotine Concentration in Blood — 3.6; 5.3; 4.0; 5.3 ng/mL
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Myblu variant A (Other); Myblu variant B (Other); Myblu variant C (Other); Myblu variant D (Other); Myblu variant E (Other); Myblu variant F (Other); Myblu variant G (Other); Myblu variant H (Other)
- Age
- Adult, Older Adult · 21+ yrs
- Sex
- All
- Sponsor
- Fontem US LLC
- Primary completion
- Jan 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Maximum Nicotine Concentration in Blood |
3.6; 5.3; 4.0; 5.3; 6.5; 4.6 | — |
| PRIMARY Concentration of Carboxyhemoglobin in Blood |
7.7; -6.25 | — |
| PRIMARY Amount of 4-(Methylnitrosamino)-1-(3-pyridyl)-1-butanol in Urine in 24 Hours |
345.4; -262.8 | — |
| PRIMARY Amount of 3-hydroxypropylmercapturic Acid in Urine in 24 Hours |
1242.2; -1097.1 | — |
| PRIMARY Amount of S-phenyl Mercapturic Acid in Urine in 24 Hours |
5.9; -5.9 | — |
| SECONDARY Level of White Blood Cells |
7.5; -0.4 | — |
| SECONDARY Spirometry: Forced Expiratory Volume in 1 Second |
2.9; 3.2 | — |
| SECONDARY Spirometry: Forced Vital Capacity |
3.8; 4.2 | — |
| SECONDARY Subjective Measure: Urge to Smoke |
70.4; 67.8; 67.2; 63.7; 62.0; 56.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04430634). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.