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

Sponsor
Fontem Ventures BV (Industry)
Overall Status
Completed
CT.gov ID
NCT03822546
Collaborator
(none)
15
1
6
29
15.7

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
None (Open Label)
Primary Purpose:
Other
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
Actual Study Start Date :
Apr 1, 2018
Actual Primary Completion Date :
Apr 30, 2018
Actual Study Completion Date :
Apr 30, 2018

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Nicotine pharmacokinetics Cmax [30 minutes following the start of product use (12 measurements over the period)]

    Mean maximum plasma nicotine concentration (Cmax)

  2. Nicotine pharmacokinetics Tmax [30 minutes following the start of product use (12 measurements over the period)]

    Median time to maximum plasma nicotine concentration (Tmax)

  3. 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

  1. 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?

  2. Incidence and nature of any adverse events (AE) [Through study completion, 6 days]

    Incidence and nature of any adverse events (AE) (Safety and Tolerability)

Eligibility Criteria

Criteria

Ages Eligible for Study:
25 Years to 65 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Celerion Lincoln Nebraska United States 68502

Sponsors and Collaborators

  • Fontem Ventures BV

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Fontem Ventures BV
ClinicalTrials.gov Identifier:
NCT03822546
Other Study ID Numbers:
  • FON-01blu-2018
First Posted:
Jan 30, 2019
Last Update Posted:
Jan 30, 2019
Last Verified:
Jan 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
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
Additional relevant MeSH terms:

Study Results

No Results Posted as of Jan 30, 2019