A Randomised, Crossover, Relative Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product, a Nicotine Inhalator and a Conventional Cigarette
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Imperial Brands PLC
- Enrollment
- 12
- Locations
- 1
- Primary Endpoint
- Nicotine Plasma Concentration
Study Overview
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.
Detailed Description
The principal part of this study evaluates the nicotine pharmacokinetic profile of conventional cigarettes, a nicotine inhalator, an unflavoured EVP and a flavoured EVP.
A second part investigates the nicotine delivery of an EVP with four different nicotine doses.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Crossover
- Primary Purpose
- Other
- Masking
- None
Eligibility Criteria
- Ages
- 21 Years to 65 Years (Adult, Older Adult)
- Sex
- Male
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Sequence 1
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.
Intervention: EVP flavoured (Other)
Sequence 1
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.
Intervention: EVP unflavoured (Other)
Sequence 1
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.
Intervention: Nicotine inhalator (Other)
Sequence 1
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.
Intervention: Conventional cigarette (Other)
Sequence 2
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.
Intervention: Conventional cigarette (Other)
Sequence 2
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.
Intervention: EVP unflavoured (Other)
Sequence 2
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.
Intervention: EVP flavoured (Other)
Sequence 2
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.
Intervention: Nicotine inhalator (Other)
Sequence 3
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.
Intervention: EVP unflavoured (Other)
Sequence 3
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.
Intervention: EVP flavoured (Other)
Sequence 3
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.
Intervention: Nicotine inhalator (Other)
Sequence 3
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.
Intervention: Conventional cigarette (Other)
Sequence 4
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.
Intervention: Conventional cigarette (Other)
Sequence 4
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.
Intervention: EVP unflavoured (Other)
Sequence 4
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.
Intervention: EVP flavoured (Other)
Sequence 4
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.
Intervention: Nicotine inhalator (Other)
Outcomes
Primary Outcomes
Nicotine Plasma Concentration
Time Frame: 1, 2, 3, 4, 5, 6, 7, 8, 10, 13, 15, 30, 45, 60 minutes, 2, 4, 6, 8, 12 and 21 hours
Maximum plasma nicotine concentration (Cmax)
Area Under the Concentration-time Curve for Plasma Nicotine (AUCt)
Time Frame: 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
- Exhaled Carbon Monoxide(25 minutes)
- Nicotine Withdrawal Symptoms(30 minutes after the third product use)
- Nicotine Craving(30 minutes after the third product use)