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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Fontem US LLC
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Concentration of Carboxyhemoglobin in Blood
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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
Arms & Interventions
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).
Intervention: Myblu variant A (Other)
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).
Intervention: Myblu variant B (Other)
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).
Intervention: Myblu variant C (Other)
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).
Intervention: Myblu variant D (Other)
BCAD
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant A (Other)
BCAD
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant B (Other)
BCAD
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant C (Other)
BCAD
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant D (Other)
CDBA
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant A (Other)
CDBA
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant B (Other)
CDBA
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant C (Other)
CDBA
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant D (Other)
DACB
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant A (Other)
DACB
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant B (Other)
DACB
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant C (Other)
GHFE
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant F (Other)
DACB
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant D (Other)
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).
Intervention: Myblu variant E (Other)
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).
Intervention: Myblu variant F (Other)
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).
Intervention: Myblu variant G (Other)
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).
Intervention: Myblu variant H (Other)
FGEH
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant E (Other)
FGEH
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant F (Other)
FGEH
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant G (Other)
FGEH
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant H (Other)
GHFE
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant E (Other)
GHFE
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant G (Other)
GHFE
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant H (Other)
HEGF
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant E (Other)
HEGF
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant F (Other)
HEGF
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant G (Other)
HEGF
Same as previous arm, but in a different randomization order.
Intervention: Myblu variant H (Other)
Outcomes
Primary Outcomes
Concentration of Carboxyhemoglobin in Blood
Time Frame: Baseline and 8 days
Change from baseline in the concentration of carboxyhemoglobin (COHb) in whole blood.
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).
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)
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).
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
- Spirometry: Forced Vital Capacity(Baseline and 8 days)
- Subjective Measure: Urge to Smoke(8 days)
- Level of White Blood Cells(Baseline and 8 days)
- Spirometry: Forced Expiratory Volume in 1 Second(Baseline and 8 days)