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

73 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-08-31

Study Completion Date

2014-05-31

Brief Summary

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The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile (rate and amount of nicotine absorbed) following a single use of the THS 2.2 Menthol (mTHS), a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a menthol cigarette (mCC) and from a single use of nicotine replacement therapy gum (NRT).

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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 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)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of mCC).

Group Type ACTIVE_COMPARATOR

mTHS

Intervention Type OTHER

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

mCC

Intervention Type OTHER

Single use of subject's own menthol cigarette (mCC)

mCC then mTHS

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).

Group Type ACTIVE_COMPARATOR

mTHS

Intervention Type OTHER

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

mCC

Intervention Type OTHER

Single use of subject's own menthol cigarette (mCC)

mTHS then NRT

Each subject will follow the below study design:

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

Group Type ACTIVE_COMPARATOR

mTHS

Intervention Type OTHER

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

NRT

Intervention Type OTHER

Single administration of 2 mg gum (Nicorette® 2mg)

NRT then mTHS

Each subject will follow the below study design:

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

Group Type ACTIVE_COMPARATOR

mTHS

Intervention Type OTHER

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

NRT

Intervention Type OTHER

Single administration of 2 mg gum (Nicorette® 2mg)

Interventions

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mTHS

Single use of Tobacco Heating System 2.2 Menthol (mTHS)

Intervention Type OTHER

mCC

Single use of subject's own menthol cigarette (mCC)

Intervention Type OTHER

NRT

Single administration of 2 mg gum (Nicorette® 2mg)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is Japanese.
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked at least 10 commercially available mCCs per day (no brand restrictions) for the last 4 weeks.
* Subject has smoked for at least the last 3 consecutive years.
* Subject does not plan to quit smoking in the next 3 months.

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 medication (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

23 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes