A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations
Study Details
Study Description
Brief Summary
This study evaluated the pharmacokinetic profiles and subjective effects of nicotine from two e-cigarette device platforms with varying concentrations of nicotine lactate (nicotine salt) e-liquid relative to conventional cigarettes. It was designed as a randomized, open-label, cross-over clinical study conducted in 15 healthy US adult smokers.
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
N/A |
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
---|---|
Experimental: Conventional cigarette The subject's preferred brand of commercially available conventional cigarette |
Other: Conventional cigarette
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
|
Active Comparator: myblu 25 mg freebase myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour |
Other: myblu 25 mg freebase
E-cigarette used for 10 inhalations every 30 seconds
|
Active Comparator: myblu 16 mg nicotine salt myblu pod-system containing 16 mg nicotine salt tobacco flavour |
Other: myblu 16 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
|
Active Comparator: myblu 25 mg nicotine salt myblu pod-system containing 25 mg nicotine salt tobacco flavour |
Other: myblu 25 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
|
Active Comparator: myblu 40 mg nicotine salt myblu pod-system containing 40 mg nicotine salt tobacco flavour |
Other: myblu 40 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
|
Active Comparator: blu PRO 48 mg nicotine salt blu PRO open-system containing 48 mg nicotine salt tobacco flavour |
Other: blu PRO 48 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
|
Outcome Measures
Primary Outcome Measures
- Nicotine pharmacokinetics Cmax [30 minutes following the start of product use (12 measurements over the period)]
Mean maximum plasma nicotine concentration (Cmax)
- Nicotine pharmacokinetics Tmax [30 minutes following the start of product use (12 measurements over the period)]
Median time to maximum plasma nicotine concentration (Tmax)
- Nicotine pharmacokinetics AUC0-30 [30 minutes following the start of product use (12 measurements over the period)]
Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30)
Secondary Outcome Measures
- Subjective effects questionnaire [20 minutes after the start of product use]
Likert-type scale with responses ranging from 1 (not at all) to 7 (extremely). The following questions were asked: Did it make you dizzy? Did it make you nauseous? Did you enjoy it? Did it relieve the urge to smoke? Was it enough nicotine? Was it too much nicotine?
- Incidence and nature of any adverse events (AE) [Through study completion, 6 days]
Incidence and nature of any adverse events (AE) (Safety and Tolerability)
Eligibility Criteria
Criteria
Inclusion Criteria:
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Having smoked ≥10 manufactured cigarettes per day for at least the last year
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Expired carbon monoxide level of >10 ppm at screening
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Tested positive for urinary cotinine (≥500 ng/mL)
Exclusion Criteria:
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Known or suspected hypersensitivity to any component of the e-liquid formulations
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Taking or receiving prescription smoking cessation medicines
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Willing or considering to stop smoking
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Smokers who draw smoke into their mouth and throat but do not inhale
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Relevant illness history
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Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2
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Breastfeeding women
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Women of child-bearing potential who were not using an accepted method of contraception
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Celerion | Lincoln | Nebraska | United States | 68502 |
Sponsors and Collaborators
- Fontem Ventures BV
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- FON-01blu-2018