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

Not Applicable

Completed

Conditions: Healthy Volunteers

Interventions: Other: Myblu flavor A_2.4
Other: Myblu flavor E_1.2
Other: Myblu flavor F_1.2
Other: Myblu flavor B_2.4
Other: Myblu flavor C_2.4
Other: Myblu flavor G_2.4
Other: Myblu flavor H_2.4
Other: Myblu flavor D_2.4

Registration Number: NCT04429932

Lead Sponsor: Fontem US LLC

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 39

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 & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Product use sequence GHFE	Myblu flavor H_2.4	Same as previous arm, but in a different randomization order.
Product use sequence HEGF	Myblu flavor F_1.2	Same as previous arm, but in a different randomization order.
Product use sequence DACB	Myblu flavor B_2.4	Same as previous arm, but in a different randomization order.
Product use sequence DACB	Myblu flavor C_2.4	Same as previous arm, but in a different randomization order.
Product use sequence ABDC	Myblu flavor C_2.4	Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% 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).
Product use sequence ABDC	Myblu flavor D_2.4	Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% 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).
Product use sequence BCAD	Myblu flavor B_2.4	Same as previous arm, but in a different randomization order.
Product use sequence BCAD	Myblu flavor C_2.4	Same as previous arm, but in a different randomization order.
Product use sequence BCAD	Myblu flavor D_2.4	Same as previous arm, but in a different randomization order.
Product use sequence CDBA	Myblu flavor A_2.4	Same as previous arm, but in a different randomization order.
Product use sequence ABDC	Myblu flavor A_2.4	Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% 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).
Product use sequence ABDC	Myblu flavor B_2.4	Subjects use MybluTM e-cigarette product variant A (2.4% nicotine) ad libitum for 2 days, then switch to use variant B (2.4% nicotine) for 2 days, then D (2.4% nicotine) for 2 days and then C (2.4% 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).
Product use sequence CDBA	Myblu flavor C_2.4	Same as previous arm, but in a different randomization order.
Product use sequence CDBA	Myblu flavor D_2.4	Same as previous arm, but in a different randomization order.
Product use sequence BCAD	Myblu flavor A_2.4	Same as previous arm, but in a different randomization order.
Product use sequence DACB	Myblu flavor A_2.4	Same as previous arm, but in a different randomization order.
Product use sequence DACB	Myblu flavor D_2.4	Same as previous arm, but in a different randomization order.
Product use sequence EFHG	Myblu flavor E_1.2	Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% 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).
Product use sequence FGEH	Myblu flavor F_1.2	Same as previous arm, but in a different randomization order.
Product use sequence FGEH	Myblu flavor G_2.4	Same as previous arm, but in a different randomization order.
Product use sequence GHFE	Myblu flavor G_2.4	Same as previous arm, but in a different randomization order.
Product use sequence HEGF	Myblu flavor G_2.4	Same as previous arm, but in a different randomization order.
Product use sequence EFHG	Myblu flavor F_1.2	Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% 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).
Product use sequence EFHG	Myblu flavor H_2.4	Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% 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).
Product use sequence GHFE	Myblu flavor E_1.2	Same as previous arm, but in a different randomization order.
Product use sequence GHFE	Myblu flavor F_1.2	Same as previous arm, but in a different randomization order.
Product use sequence HEGF	Myblu flavor E_1.2	Same as previous arm, but in a different randomization order.
Product use sequence EFHG	Myblu flavor G_2.4	Subjects use MybluTM e-cigarette product variant E (1.2% nicotine) ad libitum for 2 days, then switch to use variant F (1.2% nicotine) for 2 days, then H (2.4% nicotine) for 2 days and then G (2.4% 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).
Product use sequence FGEH	Myblu flavor E_1.2	Same as previous arm, but in a different randomization order.
Product use sequence FGEH	Myblu flavor H_2.4	Same as previous arm, but in a different randomization order.
Product use sequence HEGF	Myblu flavor H_2.4	Same as previous arm, but in a different randomization order.

Primary Outcome Measures

Name	Time	Method
Concentration of Carboxyhemoglobin in Blood	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	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	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	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	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 Outcome Measures

Name	Time	Method
Level of White Blood Cells	Baseline and 8 days	The change from baseline in the level of white blood cells, a biomarker of potential harm.
Subjective Measure: Urge to Smoke	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. 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.
Spirometry: Forced Expiratory Volume in 1 Second	Baseline and 8 days	The percent-predicted 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.
Spirometry: Forced Vital Capacity	Baseline and 8 days	The percent-predicted 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.