Nicotine Pharmacokinetic Profile and Safety of the Tobacco Heating System 2.2 Menthol (THS 2.2 Menthol)

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

64 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-05-31

Brief Summary

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The primary objective of the study is to evaluate the pharmacokinetic (PK) profiles (rate and amount of nicotine absorbed) after a single use of the THS 2.2 Menthol (mTHS 2.2) compared to a single use of the menthol conventional cigarette (mCC) and nicotine nasal spray (NNS).

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Detailed Description

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Conditions

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Smoking

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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mTHS 2.2 then mCC

Each subject will follow the below study design:

* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of mTHS 2.2)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mCC).

Group Type ACTIVE_COMPARATOR

mTHS 2.2

Intervention Type OTHER

Single use of mTHS 2.2

mCC

Intervention Type OTHER

Single use of subject's own mCC

mCC then mTHS 2.2

Each subject will follow the below study design:

* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of mCC)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mTHS 2.2).

Group Type ACTIVE_COMPARATOR

mTHS 2.2

Intervention Type OTHER

Single use of mTHS 2.2

mCC

Intervention Type OTHER

Single use of subject's own mCC

mTHS 2.2 then NNS

Each subject will follow the below study design:

* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of mTHS 2.2)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single administration of NNS)

Group Type ACTIVE_COMPARATOR

mTHS 2.2

Intervention Type OTHER

Single use of mTHS 2.2

NNS

Intervention Type OTHER

Single administration of 1 mg of nicotine

NNS then mTHS 2.2

Each subject will follow the below study design:

* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single administration of NNS)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mTHS 2.2).

Group Type ACTIVE_COMPARATOR

mTHS 2.2

Intervention Type OTHER

Single use of mTHS 2.2

NNS

Intervention Type OTHER

Single administration of 1 mg of nicotine

Interventions

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mTHS 2.2

Single use of mTHS 2.2

Intervention Type OTHER

mCC

Single use of subject's own mCC

Intervention Type OTHER

NNS

Single administration of 1 mg of nicotine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is aged from 22 to 65 years (inclusive).
* Smoking, healthy subject as judged by the Investigator.
* Subject smoked at least 10 commercially available menthol CCs per day (with brand restrictions) over the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.

Exclusion Criteria

* As per Investigator judgment, the subject cannot participate in the study for any reason (e.g., medical, psychiatric, and/or social reason).
* Subject has received medication within 14 days or within 5 half-lives of a drug (whichever is longer) which has an impact on CYP2A6 activity.
* Female subject is pregnant or breast feeding.
* Female subject does not agree to use an acceptable method of effective contraception.

Minimum Eligible Age

22 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes