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

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2014-07-31

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 compared to the PK profiles from a single use of a conventional cigarette (CC) and from a single use of 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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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 conventional 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 conventional cigarette (CC)

THS 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 THS 2.2)
* Day 2 = wash-out
* Day 3 = 2nd intervention (single administration of NNS)

Group Type ACTIVE_COMPARATOR

THS 2.2

Intervention Type OTHER

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

NNS

Intervention Type OTHER

Single administration of 1 mg of nicotine

NNS 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 NNS)
* 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)

NNS

Intervention Type OTHER

Single administration of 1 mg of nicotine

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 conventional cigarette (CC)

Intervention Type OTHER

NNS

Single administration of 1 mg of nicotine

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Subject is Caucasian
* Smoking, healthy subject as judged by the Investigator.
* Subject has smoked at least 10 commercially available non menthol CCs 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 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

21 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes