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

Primary Purpose

Tobacco Dependence

Status

Completed

Phase

Not Applicable

Locations

Sweden

Study Type

Interventional

Intervention

6 mg Experimental nicotine gum

4 mg Nicotine Gum/

2 mg Nicotine Gum

About this trial

This is an interventional basic science 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 subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and 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.

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.

Sites / Locations

McNeil AB Clinical Pharmacology R&D

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

NIC-6

NIC-4

NIC-2

Arm Description

6 mg Experimental nicotine gum

4 mg Nicotine Gum

2 mg Nicotine Gum

Outcomes

Primary Outcome Measures

Maximum Observed Plasma Concentration (Cmax)

Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

Area Under the Curve (AUC)(0-t)

AUC(0-t), whitch is the area under the plasma concentration-vs.-time curve from start of drug administration until the time of the last measurable plasma concentration, calculated as hour * nanograms (ng) per milliliter (mL).

AUC(0-∞)

AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Secondary Outcome Measures

Full Information

NCT ID

NCT01234792

First Posted

November 3, 2010

Last Updated

July 6, 2012

Sponsor

McNeil AB

1. Study Identification

Unique Protocol Identification Number

NCT01234792

Brief Title

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

Official Title

Single-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

May 2008 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (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

Single-dose nicotine pharmacokinetics with three oral nicotine replacement products.

Detailed Description

The study is a single-dose, randomized, crossover study with 24 subjects (all subjects will receive all treatments). The investigational products will be 6 mg, 4 mg and 2 mg Nicotine medicated gum given as single doses at separate treatment visits. Periods without NRT, lasting for at least 36 hours, will separate treatment visits. Blood for pharmacokinetic analyses will be drawn before, and at 2.5, 5, 7.5, 10, 15, 20, 30, 45, and 60 minutes as well as after 1.5, 2, 4, 6, and 8 hours after start of product administration. Subjects will also be monitored to capture any adverse events that may occur. The trial is blind in the sense that treatment labels will not be revealed to subjects and trial personnel. Also the bioanalysts, pharmacokineticists and monitor will be unaware of treatment labels.

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

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

NIC-6

Arm Type

Experimental

Arm Description

6 mg Experimental nicotine gum

Arm Title

NIC-4

Arm Type

Active Comparator

Arm Description

4 mg Nicotine Gum

Arm Title

NIC-2

Arm Type

Active Comparator

Arm Description

2 mg Nicotine Gum

Intervention Type

Drug

Intervention Name(s)

6 mg Experimental nicotine gum

Other Intervention Name(s)

Not marketed

Intervention Description

A single 6 mg dose of an experimental nicotine gum, with a 36-hour washout between visits

Intervention Type

Drug

Intervention Name(s)

4 mg Nicotine Gum/

Other Intervention Name(s)

Nicorette® Gum

Intervention Description

A single 4 mg dose of Nicorette® gum, with a 36-hour washout between visits

Intervention Type

Drug

Intervention Name(s)

2 mg Nicotine Gum

Other Intervention Name(s)

Nicorette® Gum

Intervention Description

A single 2 mg dose of Nicorette® gum, with a 36-hour washout between visits

Primary Outcome Measure Information:

Title

Maximum Observed Plasma Concentration (Cmax)

Description

Cmax, which is the maximum observed plasma concentration, measured in nanograms/milliliter (ng/mL)

Time Frame

During 8 hours post-dose

Title

Area Under the Curve (AUC)(0-t)

Description

Time Frame

During 8 hours post-dose

Title

AUC(0-∞)

Description

AUC(0-∞), which is the area under the plasma concentration-vs.-time curve from start of drug administration until infinity.

Time Frame

8 hours post-dose

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 subjects, smoking at least 15 cigarettes daily during at least one year preceding inclusion and 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. 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.

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

Learn more about this trial

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

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