Nicotine Pharmacokinetic Profile of the CHTP 1.1 M

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-05-31

Study Completion Date

2015-11-30

Brief Summary

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The primary objective of this clinical study is to evaluate the pharmacokinetic (PK) profile of nicotine (rate and amount of nicotine absorbed) after single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M), a potential Modified Risk Tobacco Product, compared to menthol cigarettes (mCC) in healthy smokers.

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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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CHTP 1.1 M then mCC

Each subject will follow the below study design:

* Day -1 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of CHTP 1.1 M)
* Day 2 = Wash-out
* Day 3 = 2nd intervention (single product use of mCC).

Group Type ACTIVE_COMPARATOR

CHTP 1.1 M

Intervention Type OTHER

Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

mCC

Intervention Type OTHER

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

mCC then CHTP 1.1 M

Each subject will follow the below study design:

* Day -1 = 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 CHTP 1.1 M).

Group Type ACTIVE_COMPARATOR

CHTP 1.1 M

Intervention Type OTHER

Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

mCC

Intervention Type OTHER

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

Interventions

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CHTP 1.1 M

Single use of the Carbon Heated Tobacco Product 1.1 Menthol (CHTP 1.1 M)

Intervention Type OTHER

mCC

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is Japanese.
* Subject is at a minimum 23 years of age.
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked for at least the last 3 years
* Subject smoked at least 10 commercially available mCCs per day over the last 4 weeks.

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

23 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes