A Bioavailability Study of Nicotine Delivered by an Electronic Vapour Product

Imperial Brands

Status: Completed

Conditions: Healthy Volunteers

Treatments: Other: EVP unflavoured; Other: Conventional cigarette; Other: EVP flavoured; Other: Nicotine inhalator

Study type: Interventional

Funder types: Industry

Identifiers

NCT02032212

ITG EVP G1 S1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 12 patients

Sex: Male

Ages: 21 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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12 participants in 4 patient groups

Sequence 1

Experimental group

Description:

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.

Treatment:

Other: Nicotine inhalator

Other: EVP flavoured

Other: Conventional cigarette

Other: EVP unflavoured

Sequence 2

Experimental group

Description:

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.

Treatment:

Other: Nicotine inhalator

Other: EVP flavoured

Other: Conventional cigarette

Other: EVP unflavoured

Sequence 3

Experimental group

Description:

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.

Treatment:

Other: Nicotine inhalator

Other: EVP flavoured

Other: Conventional cigarette

Other: EVP unflavoured

Sequence 4

Experimental group

Description:

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.

Treatment:

Other: Nicotine inhalator

Other: EVP flavoured

Other: Conventional cigarette

Other: EVP unflavoured