NCT02032212

Brief Summary

Electronic Vapour Products (EVPs) are a relatively new class of consumer products that are otherwise known as electronic cigarettes. These may look like conventional cigarettes but do not contain tobacco. The 'vapour' produced by such devices typically consists of humectants (propylene glycol or glycerol), nicotine, water, and flavours. This trial is to evaluate the pharmacokinetic profile of an EVP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
12

participants targeted

Target at below P25 for not_applicable healthy-volunteers

Timeline
Completed

Started Dec 2013

Typical duration 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

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 6, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
5 months until next milestone

Results Posted

Study results publicly available

May 2, 2016

Completed
Last Updated

September 10, 2025

Status Verified

September 1, 2025

Enrollment Period

5 months

First QC Date

January 6, 2014

Results QC Date

February 12, 2016

Last Update Submit

September 9, 2025

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (2)

  • Nicotine Plasma Concentration

    Maximum plasma nicotine concentration (Cmax)

    1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours

  • Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)

    1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours

Secondary Outcomes (3)

  • Exhaled Carbon Monoxide

    25 minutes

  • Nicotine Withdrawal Symptoms

    30 minutes after the third product use

  • Nicotine Craving

    30 minutes after the third product use

Study Arms (4)

Sequence 1

EXPERIMENTAL

Subjects use the unflavoured EVP on Day 1, the flavoured EVP on Day 2, the nicotine inhalator on Day 3 and the conventional cigarette on Day 4.

Other: EVP unflavouredOther: EVP flavouredOther: Nicotine inhalatorOther: Conventional cigarette

Sequence 2

EXPERIMENTAL

Subjects use the flavoured EVP on Day 1, the unflavoured EVP on Day 2, the conventional cigarette on Day 3 and the nicotine inhalator on Day 4.

Other: EVP unflavouredOther: EVP flavouredOther: Nicotine inhalatorOther: Conventional cigarette

Sequence 3

EXPERIMENTAL

Subjects use the nicotine inhalator on Day 1, the conventional cigarette on Day 2, the unflavoured EVP on Day 3 and the flavoured EVP on Day 4.

Other: EVP unflavouredOther: EVP flavouredOther: Nicotine inhalatorOther: Conventional cigarette

Sequence 4

EXPERIMENTAL

Subjects use the conventional cigarette on Day 1, the nicotine inhalator on Day 2, the flavoured EVP on Day 3 and the unflavoured EVP on Day 4.

Other: EVP unflavouredOther: EVP flavouredOther: Nicotine inhalatorOther: Conventional cigarette

Interventions

EVP unflavouredOTHER
Sequence 1Sequence 2Sequence 3Sequence 4
EVP flavouredOTHER
Sequence 1Sequence 2Sequence 3Sequence 4
Nicotine inhalatorOTHER

15 mg nicotine Nicorette

Sequence 1Sequence 2Sequence 3Sequence 4
Conventional cigaretteOTHER
Sequence 1Sequence 2Sequence 3Sequence 4

Eligibility Criteria

Age21 Years - 65 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • BMI of 18-35kg/m2
  • Subjects must be established smokers
  • Subjects must have smoked five to 30 cigarettes per day for at least one year

You may not qualify if:

  • Subjects who have used nicotine replacement therapy within 14 days of the screening
  • Subjects who have donated blood within 12 months preceding study
  • Subjects with relevant illness history
  • Subjects positive for hepatitis or HIV
  • Subjects with history of drug or alcohol abuse
  • Subjects with lung function test or vital signs considered unsuitable
  • Subjects who are trying to stop smoking

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Simbec Research

Merthyr Tydfil, Wales, CF48 4DR, United Kingdom

Location

Results Point of Contact

Title
Tanvir Walele
Organization
Imperial Tobacco Group
tanvir.walele@uk.imptob.com
0044 177 933 7589

Study Officials

  • Girish Sharma, MD

    Simbec Research

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

January 6, 2014

First Posted

January 9, 2014

Study Start

December 1, 2013

Primary Completion

May 1, 2014

Study Completion

December 1, 2015

Last Updated

September 10, 2025

Results First Posted

May 2, 2016

Record last verified: 2025-09

Data Sharing

IPD Sharing
Will not share

Locations

GB(1)