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

Fontem US

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: Myblu variant F; Other: Myblu variant D; Other: Myblu variant H; Other: Myblu variant E; Other: Myblu variant A; Other: Myblu variant G; Other: Myblu variant C; Other: Myblu variant B

Study type: Interventional

Funder types: Industry

Identifiers

NCT04430634

CA22749

Details and patient eligibility

About

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.

Enrollment: 40 patients

Sex: All

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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40 participants in 8 patient groups

ABDC

Experimental group

Description:

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).

Treatment:

Other: Myblu variant C

Other: Myblu variant D

Other: Myblu variant A

Other: Myblu variant B

BCAD

Experimental group

Description:

Same as previous arm, but in a different randomization order.

Treatment:

Other: Myblu variant C

Other: Myblu variant D

Other: Myblu variant A

Other: Myblu variant B

CDBA

Experimental group

Description:

Same as previous arm, but in a different randomization order.

Treatment:

Other: Myblu variant C

Other: Myblu variant D

Other: Myblu variant A

Other: Myblu variant B

DACB

Experimental group

Description:

Same as previous arm, but in a different randomization order.

Treatment:

Other: Myblu variant C

Other: Myblu variant D

Other: Myblu variant A

Other: Myblu variant B

EFHG

Experimental group

Description:

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).

Treatment:

Other: Myblu variant G

Other: Myblu variant H

Other: Myblu variant F

Other: Myblu variant E

FGEH

Experimental group

Description:

Same as previous arm, but in a different randomization order.

Treatment:

Other: Myblu variant G

Other: Myblu variant H

Other: Myblu variant F

Other: Myblu variant E

GHFE

Experimental group

Description:

Same as previous arm, but in a different randomization order.

Treatment:

Other: Myblu variant G

Other: Myblu variant H

Other: Myblu variant F

Other: Myblu variant E

HEGF

Experimental group

Description:

Same as previous arm, but in a different randomization order.

Treatment:

Other: Myblu variant G

Other: Myblu variant H

Other: Myblu variant F

Other: Myblu variant E