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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

65 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-07-31

Study Completion Date

2014-04-30

Brief Summary

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The overall goal of the study is to evaluate the pharmacokinetic (PK) profile (rate and the amount of nicotine absorbed) following a single use of the THS 2.2, a candidate Modified Risk Tobacco Product, compared to the PK profiles from a single use of a cigarette (CC) and from a single use of nicotine gum in a Japanese population.

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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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THS 2.2 then CC

Each subject will follow the below study design:

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

Group Type ACTIVE_COMPARATOR

THS 2.2

Intervention Type OTHER

Single use of the Tobacco Heating System 2.2 (THS 2.2)

CC

Intervention Type OTHER

Single use of subject's own cigarette (CC)

CC then THS 2.2

Each subject will follow the below study design:

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

Group Type ACTIVE_COMPARATOR

THS 2.2

Intervention Type OTHER

Single use of the Tobacco Heating System 2.2 (THS 2.2)

CC

Intervention Type OTHER

Single use of subject's own cigarette (CC)

THS 2.2 then NRT

Each subject will follow the below study design:

* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single product use of THS 2.2)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single administration of NRT gum \[Nicorette® 2mg\]).

Group Type ACTIVE_COMPARATOR

THS 2.2

Intervention Type OTHER

Single use of the Tobacco Heating System 2.2 (THS 2.2)

NRT Gum

Intervention Type OTHER

Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

NRT then THS 2.2

Each subject will follow the below study design:

* Day 0 = Wash-out (1 day)
* Day 1 = 1st intervention (single administration of NRT gum \[Nicorette® 2mg\])
* Day 2 = wash-out
* Day 3 = 2nd intervention (single product use of THS 2.2).

Group Type ACTIVE_COMPARATOR

THS 2.2

Intervention Type OTHER

Single use of the Tobacco Heating System 2.2 (THS 2.2)

NRT Gum

Intervention Type OTHER

Single administration of the nicotine replacement therapy (NRT) 2 mg gum (Nicorette® 2mg)

Interventions

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THS 2.2

Single use of the Tobacco Heating System 2.2 (THS 2.2)

Intervention Type OTHER

CC

Single use of subject's own cigarette (CC)

Intervention Type OTHER

NRT Gum

Single administration of the nicotine replacement therapy (NRT) 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 smokes at least 10 commercially available CCs per day (no brand restrictions) for the last 4 weeks.
* 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 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

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes