A Study to Assess the Nicotine Pharmacokinetics, Tolerability and Safety With a New Oral Nicotine Replacement Product in Healthy Japanese Smokers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-22

Study Completion Date

2018-04-16

Brief Summary

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In Part 1, the purpose of this study is to elucidate the single-dose pharmacokinetic profiles of 1 spray and 2 consecutive sprays of oromucosal nicotine spray (ONS) in comparison with those of nicotine gum and cigarette smoking in healthy Japanese smokers. In Part 2, the purpose is to evaluate the multiple-dose nicotine pharmacokinetics of ONS administered repeated-dose administration in healthy Japanese smokers.

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Detailed Description

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Conditions

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Healthy

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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Part 1; Treatment Sequence ABDC

Participants will receive Treatment A (one spray of oromucosal nicotine spray \[ONS\]) at Visit 1, then Treatment B (2 consecutive sprays of ONS at Visit 2, then Treatment D (1 cigarette \[10 puffs\]) at Visit 3, followed by Treatment C (nicotine gum) at Visit 4. The visits will be separated by a period of at least 7 calendar days.

Group Type EXPERIMENTAL

Oromucosal Nicotine Spray (ONS)

Intervention Type DRUG

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Nicotine Gum

Intervention Type DRUG

Participants will chew nicotine gum for 30 minutes.

Cigarette

Intervention Type OTHER

Participants will smoke one cigarette as 10 puffs for 3 minutes.

Part 1; Treatment Sequence BCAD

Participants will receive Treatment B at Visit 1, then Treatment C at Visit 2, then Treatment A at Visit 3 followed by Treatment D at Visit 4. The visits will be separated by a period of at least 7 calendar days.

Group Type EXPERIMENTAL

Oromucosal Nicotine Spray (ONS)

Intervention Type DRUG

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Nicotine Gum

Intervention Type DRUG

Participants will chew nicotine gum for 30 minutes.

Cigarette

Intervention Type OTHER

Participants will smoke one cigarette as 10 puffs for 3 minutes.

Part 1; Treatment Sequence CDBA

Participants will receive Treatment C at Visit 1, then Treatment D at Visit 2, then Treatment B at Visit 3 followed by Treatment A at Visit 4. The visits will be separated by a period of at least 7 calendar days. The visits will be separated by a period of at least 7 calendar days.

Group Type EXPERIMENTAL

Oromucosal Nicotine Spray (ONS)

Intervention Type DRUG

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Nicotine Gum

Intervention Type DRUG

Participants will chew nicotine gum for 30 minutes.

Cigarette

Intervention Type OTHER

Participants will smoke one cigarette as 10 puffs for 3 minutes.

Part 1; Treatment Sequence DACB

Participants will receive Treatment D at Visit 1, then Treatment A at Visit 2, then Treatment C at Visit 3 followed by Treatment B at Visit 4. The visits will be separated by a period of at least 7 calendar days.

Group Type EXPERIMENTAL

Oromucosal Nicotine Spray (ONS)

Intervention Type DRUG

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Nicotine Gum

Intervention Type DRUG

Participants will chew nicotine gum for 30 minutes.

Cigarette

Intervention Type OTHER

Participants will smoke one cigarette as 10 puffs for 3 minutes.

Part 2; Treatment Sequence EF

Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment E (two consecutive sprays of ONS once every 30 minutes until 11.5 hours) at Visit 5, followed by Treatment F (two consecutive sprays of ONS once every 1 hour until 11 hours) at Visit 6. The visits will be separated by a period of at least 7 calendar days.

Group Type EXPERIMENTAL

Oromucosal Nicotine Spray (ONS)

Intervention Type DRUG

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Part 2; Treatment Sequence FE

Participants who complete Part 1 will be selected for Part 2 based on the results of genetic polymorphism test and other examinations. Selected participants will receive Treatment F at Visit 5 followed by Treatment E at Visit 6. The visits will be separated by a period of at least 7 calendar days.

Group Type EXPERIMENTAL

Oromucosal Nicotine Spray (ONS)

Intervention Type DRUG

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Interventions

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Oromucosal Nicotine Spray (ONS)

Participants will receive oral dose of oromucosal nicotine spray (ONS).

Intervention Type DRUG

Nicotine Gum

Participants will chew nicotine gum for 30 minutes.

Intervention Type DRUG

Cigarette

Participants will smoke one cigarette as 10 puffs for 3 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy male or female Japanese participants between the ages of 20 and 50 years, inclusive. Health is defined as the absence of clinically relevant abnormalities identified by a detailed medical history, blood pressure, pulse rate measurements, 12-lead electrocardiogram (ECG) as well as clinical laboratory tests, as judged by the principal investigator or sub investigator.
* Smoking of at least 15 cigarettes daily during at least one year preceding inclusion
* Body Mass Index between 17.5 and 30.0 kilogram per square meter (kg/m\^2) and a total body weight greater than or equal to (\>=) 50.0 kg
* Evidence of a personally signed and dated informed consent document indicating that the participant has been informed of all pertinent aspects of the study
* All women of childbearing potential, except for postmenopausal females, must have a negative urine beta-human chorionic gonadotropin (beta-hCG) at screening of Part 1 and all planned visits of Part 1 and Part 2

Exclusion Criteria

* Evidence or history of an acute or chronic medical or psychiatric condition or allergy or laboratory abnormality, or of use of drugs that, in the judgment of the principal investigator or sub investigator, increase the risk associated with study participation or interfere with the interpretability of study results
* Females: Pregnancy, breast-feeding, premenopausal, or perimenopausal state with insufficient contraception
* Treatment with an investigational drug within 3 months preceding the first dose of study product
* Participant has donated blood or blood product or had substantial loss of blood more than 200 milliliter (mL) within 1 month before study products administration, or greater than or equal to (\>=) 400 mL within 3 months for males and 4 months for females before study products administration, or participant has donated a total volume of blood in the past one year exceeding 1,200 mL for males and 800 mL for females, or participant has an intention to donate blood or blood products during the study and for at least 3 months for males and 4 months for females for blood, or at least 2 months for both genders for blood products after completion of the study
* Exclusion Criterion for Only Part 2: participants who is analyzed as cytochrome (CYP)2A6 \*4/\*4 by CYP2A6 genetic polymorphism test at Visit 1 of Part 1

Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes