NCT04780815

Brief Summary

This is a single-center, exploratory positron emission tomography (PET) study of deposition, disposition and brain uptake \[11C\]nicotine when given to smokers as two different formulations via mybluTM e-cigarette system.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
16

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Mar 2020

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

March 16, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 17, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2021

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 4, 2021

Completed
2.2 years until next milestone

Results Posted

Study results publicly available

May 19, 2023

Completed
Last Updated

May 19, 2023

Status Verified

July 1, 2022

Enrollment Period

8 months

First QC Date

February 23, 2021

Results QC Date

July 8, 2022

Last Update Submit

July 8, 2022

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (3)

  • Lung PET

    Peak accumulation of \[11C\]nicotine deposited in the lung during 40 minutes after product administration, using dynamic PET Digital Imaging and Communications in Medicine (DICOM) images over the lungs

    40 minutes

  • Oral Cavity PET

    Peak accumulation of nicotine deposited in the oral cavity during 40 minutes after product administration, using dynamic PET Digital Imaging and Communications in Medicine (DICOM) images over the oral cavity

    40 minutes

  • Brain PET

    Peak accumulation of nicotine deposited in the brain during 30 minutes after product administration, using dynamic PET Digital Imaging and Communications in Medicine (DICOM) images over the brain

    30 minutes

Study Arms (4)

myBluTM Formulation 1 Oral cavity and lungs

EXPERIMENTAL

This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 1

Other: myBluTM Formulation 1

myBluTM Formulation 2 Oral cavity and lungs

EXPERIMENTAL

This group was used for measuring oral cavity and lungs endpoints after administration of Formulation 2

Other: myBluTM Formulation 2

myBluTM Formulation 1 Brain

EXPERIMENTAL

This group was used for measuring brain endpoints after administration of Formulation 1

Other: myBluTM Formulation 1

myBluTM Formulation 2 Brain

EXPERIMENTAL

This group was used for measuring brain endpoints after administration of Formulation 2

Other: myBluTM Formulation 2

Interventions

myBluTM Formulation 1OTHER

1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 1, with inhalation of the vapour into the lungs

myBluTM Formulation 1 BrainmyBluTM Formulation 1 Oral cavity and lungs
myBluTM Formulation 2OTHER

1-2 puffs of each 3-5 seconds duration taken from myBluTM with Formulation 2, with inhalation of the vapour into the lungs

myBluTM Formulation 2 BrainmyBluTM Formulation 2 Oral cavity and lungs

Eligibility Criteria

Age50 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Body mass index ≥18.0 and ≤ 30.0 kg/m2
  • Habitual daily cigarette smoker
  • Women have to be of non-child bearing potential

You may not qualify if:

  • History of any clinically significant disease
  • Relevant concomitant medication
  • Any clinically significant condition
  • Malignancy within the past 5 years
  • Positif for HIV, hepatitis B or C
  • Untreated hypertension
  • Previous participation to a PET-study or other nuclide medical study
  • Previous exposure to significant radiation
  • Negative results of the modified Allen test on both arms at screening
  • Alcohol or drug abuse

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PET Centre, Uppsala University Hospital

Uppsala, SE-751 85, Sweden

Location

Results Point of Contact

Title
Simon McDermott
Organization
ImperialBrands PLC
simon.mcdermott@uk.imptob.com
+44 (0)117 332 0225

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

February 23, 2021

First Posted

March 4, 2021

Study Start

March 16, 2020

Primary Completion

November 17, 2020

Study Completion

November 17, 2020

Last Updated

May 19, 2023

Results First Posted

May 19, 2023

Record last verified: 2022-07

Data Sharing

IPD Sharing
Will not share

Locations

SE(1)