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

Fontem Ventures BV15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Healthy Volunteers

Interventions

Conventional cigaretteOTHER

Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals

myblu 25 mg freebaseOTHER

E-cigarette used for 10 inhalations every 30 seconds

myblu 16 mg nicotine saltOTHER

E-cigarette used for 10 inhalations every 30 seconds

Eligibility

Sex: ALLMin age: 25 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Celerion

Lincoln, Nebraska, United States

Outcomes

Primary Outcomes

Nicotine pharmacokinetics Cmax

Mean maximum plasma nicotine concentration (Cmax)

Time frame: 30 minutes following the start of product use (12 measurements over the period)

Nicotine pharmacokinetics Tmax

Median time to maximum plasma nicotine concentration (Tmax)

Time frame: 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)

Time frame: 30 minutes following the start of product use (12 measurements over the period)

Secondary Outcomes

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?

Time frame: 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)

Time frame: Through study completion, 6 days

Data from ClinicalTrials.gov

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