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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Healthy Volunteers
- Sponsor
- Fontem Ventures BV
- Enrollment
- 15
- Locations
- 1
- Primary Endpoint
- Nicotine pharmacokinetics Cmax
- Status
- Completed
- Last Updated
- 7 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Nicotine pharmacokinetics Cmax
Time Frame: 30 minutes following the start of product use (12 measurements over the period)
Mean maximum plasma nicotine concentration (Cmax)
Nicotine pharmacokinetics Tmax
Time Frame: 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
Time Frame: 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 Outcomes
- Subjective effects questionnaire(20 minutes after the start of product use)
- Incidence and nature of any adverse events (AE)(Through study completion, 6 days)