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Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

Oral Nicotine

Nicotine Lozenge

Nicotine gum

About this trial

This is an interventional treatment trial for Tobacco Dependence focused on measuring Smoking Cessation, Nicotine pharmacokinetics

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2.
Female participants of child-bearing potential are required to use a medically acceptable means of birth control.
A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study.

Exclusion Criteria:

Pregnancy, lactation or intended pregnancy.
Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication.
Prior regular use of nicotine mouth spray

Sites / Locations

Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Arm Label

Oral Nicotine 24-SA

Oral Nicotine 24

Oral Nicotine 48

NiQuitin™ Lozenge 4 mg

Nicorette® Gum 4 mg

Arm Description

2 Self-administrations of Experimental Nicotine once every hour

2 administrations of Experimental Nicotine by study personnel once every hour

2 administrations of Experimental Nicotine by study personnel once every 30 minutes

1 NiQuitin™ lozenge, administered by study personnel once every hour

1 piece Nicorette® gum, chewed for 30 minutes once every hour

Outcomes

Primary Outcome Measures

Maximum Plasma Concentration

Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

Average Concentration

Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)

Secondary Outcome Measures

Time of Maximum Concentration

The time at which maximum concentration is reached (Tmax)

Minimum Plasma Concentration

The minimum nicotine plasma concentration during the last dosing interval (Cmin)

Peak-Trough Fluctuation

Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)

Nicotine Plasma Concentration

The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment

Full Information

NCT ID

NCT01084707

First Posted

March 9, 2010

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01084707

Brief Title

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

Official Title

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product. A Study in Healthy Smokers.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

January 2009 (undefined)

Primary Completion Date

March 2009 (Actual)

Study Completion Date

April 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

McNeil AB

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after multiple-doses of nicotine.

Detailed Description

This study compares a new oral Nicotine Replacement Therapy (NRT) product with NiQuitin™ lozenge 4 mg and Nicorette®gum 4 mg, after 12 hours of nicotine abstinence, with respect to steady-state nicotine pharmacokinetics, during 12 hours after start of the first administration. Multiple doses of each treatment are given once hourly during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 40 healthy smokers between 18-50 years, who have been smoking at least 20 cigarettes daily during at least one year preceding inclusion. Subjects and study personnel will be aware of which treatment is administered at a given visit.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Dependence

Keywords

Smoking Cessation, Nicotine pharmacokinetics

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

40 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Nicotine 24-SA

Arm Type

Experimental

Arm Description

2 Self-administrations of Experimental Nicotine once every hour

Arm Title

Oral Nicotine 24

Arm Type

Experimental

Arm Description

2 administrations of Experimental Nicotine by study personnel once every hour

Arm Title

Oral Nicotine 48

Arm Type

Experimental

Arm Description

2 administrations of Experimental Nicotine by study personnel once every 30 minutes

Arm Title

NiQuitin™ Lozenge 4 mg

Arm Type

Active Comparator

Arm Description

1 NiQuitin™ lozenge, administered by study personnel once every hour

Arm Title

Nicorette® Gum 4 mg

Arm Type

Active Comparator

Arm Description

1 piece Nicorette® gum, chewed for 30 minutes once every hour

Intervention Type

Drug

Intervention Name(s)

Oral Nicotine

Other Intervention Name(s)

generic Nicotine

Intervention Description

Oral Nicotine either self-administered or provided by study personnel within 12 hours

Intervention Type

Drug

Intervention Name(s)

Nicotine Lozenge

Other Intervention Name(s)

NiQuitin™

Intervention Description

Nicotine lozenge marketed as NiQuitin™ 4 mg hourly within 12 hours

Intervention Type

Drug

Intervention Name(s)

Nicotine gum

Other Intervention Name(s)

Nicorette®

Intervention Description

Nicotine gum marketed as Nicorette® 4 mg hourly within 12 hours

Primary Outcome Measure Information:

Title

Maximum Plasma Concentration

Description

Cmax, which is the maximum (peak) concentration (amount of drug) measurable in blood plasma after a dose is administered measured in nanograms/milliliter (ng/ml)

Time Frame

During the last dosing interval (hour 11-12 post-dose)

Title

Average Concentration

Description

Pharmacokinetic measurement - average concentration during the last dosing interval (AUCtau)

Time Frame

During the last dosing interval (hour 11-12 post-dose)

Secondary Outcome Measure Information:

Title

Time of Maximum Concentration

Description

The time at which maximum concentration is reached (Tmax)

Time Frame

During the last dosing interval (hour 11-12 post-dose)

Title

Minimum Plasma Concentration

Description

The minimum nicotine plasma concentration during the last dosing interval (Cmin)

Time Frame

During the last dosing interval (hour 11-12 post-dose)

Title

Peak-Trough Fluctuation

Description

Percent of peak-trough fluctuation over one dosing interval at steady state (PTF)

Time Frame

During the last dosing interval (hour 11-12 post-dose)

Title

Nicotine Plasma Concentration

Description

The nicotine concentration in plasma (area under the nicotine plasma concentration curve) 1 hour after start of treatment

Time Frame

One hour after start of treatment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy smokers, smoking at least 20 cigarettes daily during at least one year preceding inclusion and BMI between 17.5 and 30.0 kg/m2. Female participants of child-bearing potential are required to use a medically acceptable means of birth control. A personally signed and dated informed consent document, indicating that the subject has been informed of all pertinent aspects of the study. Exclusion Criteria: Pregnancy, lactation or intended pregnancy. Treatment with an investigational product or donation or loss of blood within 3 month preceding the first dose of study medication. Prior regular use of nicotine mouth spray

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Elisabeth Kruse, PhD

Organizational Affiliation

McNeil AB

Official's Role

Study Director

Facility Information:

Facility Name

Clinical Pharmacology

City

Lund

ZIP/Postal Code

222 20

Country

Sweden

12. IPD Sharing Statement

Learn more about this trial

Multiple-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product.

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