Healthy Volunteers
Conditions
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.
Interventions
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
OTHERmyblu 25 mg freebase
E-cigarette used for 10 inhalations every 30 seconds
OTHERmyblu 16 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
OTHERmyblu 25 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
OTHERmyblu 40 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
OTHERblu PRO 48 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
Sponsors
Fontem Ventures BV
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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) |
Countries
United States
Outcome results
None listed