A Study to Assess Tobacco-related Biomarkers of Exposure in Smokers Using myBlu E-cigarettes

An Open-label, Parallel Study to Assess Tobacco-related Biomarkers of Exposure, Biomarkers of Potential Harm, and Nicotine Uptake During a 56-day Switch to Myblu E-cigarettes in Adult Smokers

Sponsors

Lead Sponsor: Fontem Ventures BV

Source Fontem Ventures BV
Brief Summary

The purpose of this study is to assess changes in exposure to selected harmful and potentially harmful substances related to tobacco/nicotine use when adult smokers switch from their usual brand of combustible cigarettes to the myblu e-cigarette. This study is designed as an open-label, partially-randomized, parallel-arm, multi-site study in healthy adult smokers.

Some subjects will be selected to take part in additional procedures as part of a pharmacokinetics sub-study.

Overall Status Recruiting
Start Date March 1, 2019
Completion Date June 2020
Primary Completion Date June 2020
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Concentration of carboxyhemoglobin in blood 56 days
Amount of 4-(methylnitrosamino)-1-(3-pyridyl)-1-butanol in urine in 24 hours 56 days
Amount of 3-hydroxypropylmercapturic acid in urine in 24 hours 56 days
Amount of s-phenyl mercapturic acid in urine in 24 hours 56 days
Secondary Outcome
Measure Time Frame
Amount of nicotine in urine in 24 hours 56 days
Level of white blood cells 56 days
Subjective Measure: Nicotine Withdrawal Symptoms 56 days
Maximum nicotine concentration in blood 180 minutes following the start of product use (11 measurements over the period)
Enrollment 200
Condition
Intervention

Intervention Type: Other

Intervention Name: Continue-smoking

Description: Ad-libitum use of subjects' usual brand combustible cigarette

Arm Group Label: Continue-smoking

Intervention Type: Other

Intervention Name: myblu Tobacco Chill 2.5%

Description: Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 2.5% nicotine

Arm Group Label: myblu Tobacco Chill 2.5%

Intervention Type: Other

Intervention Name: myblu Tobacco Chill 4.0%

Description: Ad-libitum use of myblu e-cigarette with Tobacco Chill flavor 4.0% nicotine

Arm Group Label: myblu Tobacco Chill 4.0%

Intervention Type: Other

Intervention Name: myblu Honeymoon 2.5%

Description: Ad-libitum use of myblu e-cigarette with Honeymoon flavor 2.5% nicotine

Arm Group Label: myblu Honeymoon 2.5%

Intervention Type: Other

Intervention Name: myblu Honeymoon 4.0%

Description: Ad-libitum use of myblu e-cigarette with Honeymoon flavor 4.0% nicotine

Arm Group Label: myblu Honeymoon 4.0%

Eligibility

Criteria:

Inclusion Criteria:

- Having smoked ≥5 manufactured combustible cigarettes per day for at least one year

- Exhaled carbon monoxide level of >10 ppm at screening

- Tested positive for urinary cotinine (approximately 200 ng/mL) at screening

Exclusion Criteria:

- Relevant illness history

- Relevant medication use

- Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2

- Allergy to propylene glycol or glycerin

- Use of nicotine-containing products other than manufactured cigarettes

- Use of prescription smoking cessation treatments

- Smokers who draw smoke into their mouth and throat but do not inhale

- Intent or desire to stop smoking

- Female subjects who are pregnant, lactating, or intend to become pregnant

Gender: All

Minimum Age: 21 Years

Maximum Age: 65 Years

Healthy Volunteers: Accepts Healthy Volunteers

Overall Contact

Last Name: Julie Saathoff

Phone: +1 402 437 4829

Email: [email protected]

Location
Facility: Status: Contact: Celerion Julie Saathoff 402-437-4829 [email protected]
Location Countries

United States

Verification Date

July 2019

Responsible Party

Type: Sponsor

Has Expanded Access No
Number Of Arms 5
Arm Group

Label: Continue-smoking

Type: Active Comparator

Description: The subject's usual brand of combustible cigarette

Label: myblu Tobacco Chill 2.5%

Type: Experimental

Description: myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 2.5% nicotine

Label: myblu Tobacco Chill 4.0%

Type: Experimental

Description: myblu e-cigarette system with Tobacco Chill flavor Intense Liquidpod, 4.0% nicotine

Label: myblu Honeymoon 2.5%

Type: Experimental

Description: myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 2.5% nicotine

Label: myblu Honeymoon 4.0%

Type: Experimental

Description: myblu e-cigarette system with Honeymoon flavor Intense Liquidpod, 4.0% nicotine

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Other

Masking: None (Open Label)

Source: ClinicalTrials.gov