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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03822546
• Other study ID #: FON-01blu-2018
• Status: Completed
• Phase: N/A
• Start date: April 1, 2018
• Est. completion date: April 30, 2018

Study information

• Verified date: January 2019
• Source: Fontem Ventures BV
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: April 30, 2018
• Est. primary completion date: April 30, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

Other:
• Conventional cigarette
Subject's own conventional cigarette brand smoked with puffs taken at 30 seconds intervals
• myblu 25 mg freebase
E-cigarette used for 10 inhalations every 30 seconds
• myblu 16 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
• myblu 25 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
• myblu 40 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds
• blu PRO 48 mg nicotine salt
E-cigarette used for 10 inhalations every 30 seconds

Locations

Country	Name	City	State
United States	Celerion	Lincoln	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Fontem Ventures BV

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Nicotine pharmacokinetics Cmax	Mean maximum plasma nicotine concentration (Cmax)	30 minutes following the start of product use (12 measurements over the period)
Primary	Nicotine pharmacokinetics Tmax	Median time to maximum plasma nicotine concentration (Tmax)	30 minutes following the start of product use (12 measurements over the period)
Primary	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	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
Secondary	Incidence and nature of any adverse events (AE)	Incidence and nature of any adverse events (AE) (Safety and Tolerability)	Through study completion, 6 days