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Single-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
NiQuitinTM Nicotine Lozenge
Nicorette® Nicotine Gum
Sponsored by
McNeil AB
About
Eligibility
Locations
Arms
Outcomes
Full info

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 15 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 months preceding the first dose of study medication.

Sites / Locations

  • Clinical Pharmacology

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Active Comparator

Active Comparator

Arm Label

Oral Nicotine 1

Oral Nicotine 2

Oral Nicotine 4

NiQuitinTM Nicotine Lozenge 4 mg

Nicorette® Gum 4 mg

Arm Description

One oral administration of 1 mg nicotine

Two oral administrations of 1 mg nicotine

Four oral administrations of 1 mg nicotine

One 4 mg marketed nicotine lozenge

One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes

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)
Bioavailability
A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).

Secondary Outcome Measures

Nicotine Plasma Concentration
Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
Time of Maximum Concentration
The time at which maximum concentration is reached (Tmax)
Terminal Elimination Rate Constant
The terminal nicotine elimination rate constant (Lamda z)
Released Nicotine
The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing

Full Information

First Posted
March 9, 2010
Last Updated
July 6, 2012
Sponsor
McNeil AB
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1. Study Identification

Unique Protocol Identification Number
NCT01084603
Brief Title
Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product
Official Title
Single-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
March 2009 (undefined)
Primary Completion Date
May 2009 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
McNeil AB

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
A comparison of three products for oral nicotine replacement with respect to pharmacokinetics after single-dose 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 nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of each treatment are given once in the morning during five separate treatment visits scheduled in a crossover setting with randomized treatment sequences. The study will include 45 healthy smokers between 18-50 years, who have been smoking at least 15 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
45 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Oral Nicotine 1
Arm Type
Experimental
Arm Description
One oral administration of 1 mg nicotine
Arm Title
Oral Nicotine 2
Arm Type
Experimental
Arm Description
Two oral administrations of 1 mg nicotine
Arm Title
Oral Nicotine 4
Arm Type
Experimental
Arm Description
Four oral administrations of 1 mg nicotine
Arm Title
NiQuitinTM Nicotine Lozenge 4 mg
Arm Type
Active Comparator
Arm Description
One 4 mg marketed nicotine lozenge
Arm Title
Nicorette® Gum 4 mg
Arm Type
Active Comparator
Arm Description
One marketed Nicorette® nicotine gum 4 mg chewed for 30 minutes
Intervention Type
Drug
Intervention Name(s)
Oral Nicotine
Other Intervention Name(s)
Experimental nicotine 1 mg
Intervention Description
A new l mg oral nicotine product
Intervention Type
Drug
Intervention Name(s)
NiQuitinTM Nicotine Lozenge
Other Intervention Name(s)
NiQuitinTM lozenge
Intervention Description
A marketed 4 mg Nicotine lozenge
Intervention Type
Drug
Intervention Name(s)
Nicorette® Nicotine Gum
Other Intervention Name(s)
Nicorette® gum
Intervention Description
A marketed 4 mg Nicotine Gum
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 12 hours after start of administration
Title
Bioavailability
Description
A measure of how much of the drug reaches a person's bloodstream within a given period of time for the body to use. The extent of product bioavailability is estimated by the area under the blood concentration vs time curve. The area under the curve (AUC) is calculated by plotting the drug's blood levels on a graph at different times during the set period to form a curve. The area under this curve reflects the amount of drug exposure in the set time period, calculated as hour*nanograms/milliliter (h*ng/ml).
Time Frame
12 hours
Secondary Outcome Measure Information:
Title
Nicotine Plasma Concentration
Description
Area under the nicotine plasma concentration curve at 10 minutes (AUC10 min)
Time Frame
During 10 minutes after start of administration
Title
Time of Maximum Concentration
Description
The time at which maximum concentration is reached (Tmax)
Time Frame
During 12 hours after start of administration
Title
Terminal Elimination Rate Constant
Description
The terminal nicotine elimination rate constant (Lamda z)
Time Frame
During 12 hours after start of administration
Title
Released Nicotine
Description
The amount of nicotine released from Nicorette® gum 4 mg during 30 minutes' chewing
Time Frame
After 30 minutes' chewing

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Healthy smokers, smoking at least 15 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 months preceding the first dose of study medication.
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

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Single-dose Nicotine Pharmacokinetics With a New Oral Nicotine Replacement Product

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