A Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations

Study Overview
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Brief Summary
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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.

Official Title
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A Randomized, Open-label, Cross-over Clinical Study to Evaluate the Pharmacokinetic Profiles of Cigarettes and E-Cigarettes With Nicotine Salt Formulations in Adult Smokers

Conditions
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Healthy Volunteers

Intervention / Treatment
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* Other: Conventional cigarette
* Other: myblu 25 mg freebase
* Other: myblu 16 mg nicotine salt
* Other: myblu 25 mg nicotine salt
* Other: myblu 40 mg nicotine salt
* Other: blu PRO 48 mg nicotine salt


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Having smoked ≥10 manufactured cigarettes per day for at least the last year Expired carbon monoxide level of >10 ppm at screening Tested positive for urinary cotinine (≥500 ng/mL) Exclusion Criteria: Known or suspected hypersensitivity to any component of the e-liquid formulations Taking or receiving prescription smoking cessation medicines Willing or considering to stop smoking Smokers who draw smoke into their mouth and throat but do not inhale Relevant illness history Body mass index (BMI) of less than 18 kg/m2 or greater than 40 kg/m2 Breastfeeding women Women of child-bearing potential who were not using an accepted method of contraception

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Conventional cigarette<br>The subject's preferred brand of commercially available conventional cigarette | Other: Conventional cigarette<br>* Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals<br>|
| Active Comparator: myblu 25 mg freebase<br>myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour | Other: myblu 25 mg freebase<br>* E-cigarette used for 10 inhalations every 30 seconds<br>|
| Active Comparator: myblu 16 mg nicotine salt<br>myblu pod-system containing 16 mg nicotine salt tobacco flavour | Other: myblu 16 mg nicotine salt<br>* E-cigarette used for 10 inhalations every 30 seconds<br>|
| Active Comparator: myblu 25 mg nicotine salt<br>myblu pod-system containing 25 mg nicotine salt tobacco flavour | Other: myblu 25 mg nicotine salt<br>* E-cigarette used for 10 inhalations every 30 seconds<br>|
| Active Comparator: myblu 40 mg nicotine salt<br>myblu pod-system containing 40 mg nicotine salt tobacco flavour | Other: myblu 40 mg nicotine salt<br>* E-cigarette used for 10 inhalations every 30 seconds<br>|
| Active Comparator: blu PRO 48 mg nicotine salt<br>blu PRO open-system containing 48 mg nicotine salt tobacco flavour | Other: blu PRO 48 mg nicotine salt<br>* E-cigarette used for 10 inhalations every 30 seconds<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Nicotine pharmacokinetics Cmax | Mean maximum plasma nicotine concentration (Cmax) | 30 minutes following the start of product use (12 measurements over the period) | 
| Nicotine pharmacokinetics Tmax | Median time to maximum plasma nicotine concentration (Tmax) | 30 minutes following the start of product use (12 measurements over the period) | 
| Nicotine pharmacokinetics AUC0-30 | Mean area under the plasma nicotine concertation-time curve, from time zero to 30 minutes (AUC0-30) | 30 minutes following the start of product use (12 measurements over the period) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective effects questionnaire | 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? | 20 minutes after the start of product use | 
| Incidence and nature of any adverse events (AE) | Incidence and nature of any adverse events (AE) (Safety and Tolerability) | Through study completion, 6 days |