NCT03822546

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2018

Shorter than P25 for not_applicable healthy-volunteers

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2018

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

December 19, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 30, 2019

Completed
Last Updated

January 30, 2019

Status Verified

January 1, 2019

Enrollment Period

29 days

First QC Date

December 19, 2018

Last Update Submit

January 29, 2019

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (2)

  • Subjective effects questionnaire

    20 minutes after the start of product use

  • Incidence and nature of any adverse events (AE)

    Through study completion, 6 days

Study Arms (6)

Conventional cigarette

EXPERIMENTAL

The subject's preferred brand of commercially available conventional cigarette

Other: Conventional cigarette

myblu 25 mg freebase

ACTIVE COMPARATOR

myblu pod-system containing 25 mg nicotine ('freebase') tobacco flavour

Other: myblu 25 mg freebase

myblu 16 mg nicotine salt

ACTIVE COMPARATOR

myblu pod-system containing 16 mg nicotine salt tobacco flavour

Other: myblu 16 mg nicotine salt

myblu 25 mg nicotine salt

ACTIVE COMPARATOR

myblu pod-system containing 25 mg nicotine salt tobacco flavour

Other: myblu 25 mg nicotine salt

myblu 40 mg nicotine salt

ACTIVE COMPARATOR

myblu pod-system containing 40 mg nicotine salt tobacco flavour

Other: myblu 40 mg nicotine salt

blu PRO 48 mg nicotine salt

ACTIVE COMPARATOR

blu PRO open-system containing 48 mg nicotine salt tobacco flavour

Other: blu PRO 48 mg nicotine salt

Interventions

Conventional cigaretteOTHER

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

Conventional cigarette
myblu 25 mg freebaseOTHER

E-cigarette used for 10 inhalations every 30 seconds

myblu 25 mg freebase
myblu 16 mg nicotine saltOTHER

E-cigarette used for 10 inhalations every 30 seconds

myblu 16 mg nicotine salt
myblu 25 mg nicotine saltOTHER

E-cigarette used for 10 inhalations every 30 seconds

myblu 25 mg nicotine salt
myblu 40 mg nicotine saltOTHER

E-cigarette used for 10 inhalations every 30 seconds

myblu 40 mg nicotine salt
blu PRO 48 mg nicotine saltOTHER

E-cigarette used for 10 inhalations every 30 seconds

blu PRO 48 mg nicotine salt

Eligibility Criteria

Age25 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Celerion

Lincoln, Nebraska, 68502, United States

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 19, 2018

First Posted

January 30, 2019

Study Start

April 1, 2018

Primary Completion

April 30, 2018

Study Completion

April 30, 2018

Last Updated

January 30, 2019

Record last verified: 2019-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)