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

Not Applicable

Completed

• Conditions: Healthy Volunteers

• Registration Number: NCT03822546
• Lead Sponsor: Fontem Ventures BV

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-04-01
• Primary Completion: 2018-04-30
• Study Completion: 2018-04-30
• Study First Submitted: 2018-12-19
• Status Verified: 2019-01
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-30
• Last Update Posted: 2019-01-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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)

Trial Locations

Locations (1)

Celerion; 🇺🇸 Lincoln, Nebraska, United States