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

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

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 Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: 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

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: OTHER
• Allocation: RANDOMIZED
• Interventional Model: CROSSOVER
• Masking: NONE

Number of Arms

6

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fontem Ventures BV

Study record dates

Study Major Dates

• Study Start (ACTUAL): April 1, 2018
• Primary Completion (ACTUAL): April 30, 2018
• Study Completion (ACTUAL): April 30, 2018

Study Registration Dates

• First Submitted: December 19, 2018
• First Submitted That Met QC Criteria: January 29, 2019
• First Posted (ACTUAL): January 30, 2019

Study Record Updates

• Last Update Posted (ACTUAL): January 30, 2019
• Last Update Submitted That Met QC Criteria: January 29, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: FON-01blu-2018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No