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Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Phase 1

Locations

Sweden

Study Type

Interventional

Intervention

Nicotine

About this trial

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

Eligibility Criteria

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

Inclusion Criteria:

Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion.
BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg.
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.
Willing and able to comply with all scheduled visits and study procedures

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.
Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.

Sites / Locations

McNeil AB Clinical Pharmacology R&D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

NRT 60

NFG 60

NRT 90

NFG 90

NIQ 60

Arm Description

A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits

A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits

A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration

Maximum Observed Plasma Concentration (Cmax), which is the maximum (peak) concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)

Average Concentration

Average Nicotine Plasma Concentration (Cav) within the last dosing interval

Area Under the Curve

Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)

Secondary Outcome Measures

Time of Maximum Concentration

The time at which maximum concentration is reached (Tmax)

Minimum Observed Concentration

Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)

Peak-Trough Fluctuation

Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)

Swing

Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin

Nicotine Released

The amount of nicotine released from the product during product administration

Full Information

NCT ID

NCT01321931

First Posted

March 22, 2011

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01321931

Brief Title

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Official Title

Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products. A Study in Healthy Smokers.

Study Type

Interventional

2. Study Status

Record Verification Date

July 2012

Overall Recruitment Status

Completed

Study Start Date

February 2011 (undefined)

Primary Completion Date

May 2011 (Actual)

Study Completion Date

June 2011 (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

Multiple-dose nicotine pharmacokinetics with three oral nicotine replacement products. A study in healthy smokers.

Detailed Description

Fifty (50) healthy male or female subjects between the ages of 19 and 50 years, inclusive, smoking at least 20 cigarettes daily during at least one year preceding inclusion. Multiple doses of all study treatments are given either every 60 minutes or every 90 minutes, respectively. All products will be administered in accordance with labeling, on five separate treatment visits. The subjects will abstain from smoking from 8 pm in the evening before and until the end of each 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

Basic Science

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

50 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NRT 60

Arm Type

Experimental

Arm Description

A 6 mg dose of an experimental Nicotine Replacement Therapy (NRT) given every hour for 11 hours, with a 36-hour washout between visits

Arm Title

NFG 60

Arm Type

Active Comparator

Arm Description

A 4 mg dose of a marketed Nicotine Fruit Gum (NFG) given every hour for 11 hours, with a 36-hour washout between visits

Arm Title

NRT 90

Arm Type

Experimental

Arm Description

A 6 mg dose of NRT given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

Arm Title

NFG 90

Arm Type

Active Comparator

Arm Description

A 4 mg dose of NFG given every 90 minutes for 10.5 hours, with a 36-hour washout between visits

Arm Title

NIQ 60

Arm Type

Active Comparator

Arm Description

A 4 mg dose of marketed nicotine mint lozenge (NIQ), given every hour for 11 hours, with a 36-hour washout between visits

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Not yet marketed

Intervention Description

6 mg experimental Nicotine Replacement Therapy (NRT)

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

Nicorette® Freshfruit Gum

Intervention Description

4 mg marketed Nicotine Fruit Gum (NFG)

Intervention Type

Drug

Intervention Name(s)

Nicotine

Other Intervention Name(s)

NiQuitinTM Mint lozenge

Intervention Description

4 mg marketed nicotine mint lozenge (NIQ)

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration

Description

Time Frame

within the last dosing interval (starting at 10.5-11 hours after first product administration)

Title

Average Concentration

Description

Average Nicotine Plasma Concentration (Cav) within the last dosing interval

Time Frame

within the last dosing interval (starting at 10.5-11 hours after first product administration)

Title

Area Under the Curve

Description

Area under the nicotine plasma concentration-vs.-time curve during the last dosing interval (AUCt)

Time Frame

within the last dosing interval (starting at 10.5-11 hours after first product administration)

Secondary Outcome Measure Information:

Title

Time of Maximum Concentration

Description

The time at which maximum concentration is reached (Tmax)

Time Frame

During 12 hours post-dose

Title

Minimum Observed Concentration

Description

Minimum Observed Plasma Concentration (Cmin), which is the minimum concentration (amount of drug) measurable in blood plasma within the last dosing interval, measured in nanograms/milliliter (ng/mL)

Time Frame

within the last dosing interval (starting at 10.5-11 hours after first product administration)

Title

Peak-Trough Fluctuation

Description

Percent of Peak-Trough Fluctuation in one dosing interval at steady state (PTF)

Time Frame

within the last dosing interval (starting at 10.5-11 hours after first product administration)

Title

Swing

Description

Swing in one dosing interval at steady state, calculated as (Cmax-Cmin)/ Cmin

Time Frame

within the last dosing interval (starting at 10.5-11 hours after first product administration)

Title

Nicotine Released

Description

The amount of nicotine released from the product during product administration

Time Frame

30 minutes

10. Eligibility

Sex

All

Minimum Age & Unit of Time

19 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy subjects, smoking at least 20 cigarettes daily during at least one year preceding inclusion. BMI between 17.5 and 30.0 kg/m2 and a total body weight of at least 55.0 kg. 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. Willing and able to comply with all scheduled visits and study procedures 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. Any medical condition or history that might, per protocol or in the opinion of the investigator, compromise subject safety or trial results.

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

McNeil AB Clinical Pharmacology R&D

City

Lund

ZIP/Postal Code

SE-222 20

Country

Sweden

12. IPD Sharing Statement

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Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

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