Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

NCT01321931 | Completed Phase 1

• 2 other identifiers: NICTDP10812010-023026-20
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Tobacco Dependence

Keywords

Smoking Cessation; Nicotine pharmacokinetics

Outcome Measures

Primary Outcomes (3)

• 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)

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

• Average Concentration

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

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

• Area Under the Curve

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

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

Secondary Outcomes (5)

• Time of Maximum Concentration

  During 12 hours post-dose

• Minimum Observed Concentration

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

• Peak-Trough Fluctuation

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

• Swing

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

• Nicotine Released

  30 minutes

Study Arms (5)

NRT 60

EXPERIMENTAL

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

Drug: Nicotine

NFG 60

ACTIVE COMPARATOR

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

Drug: Nicotine

NRT 90

EXPERIMENTAL

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

Drug: Nicotine

NFG 90

ACTIVE COMPARATOR

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

Drug: Nicotine

NIQ 60

ACTIVE COMPARATOR

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

Drug: Nicotine

Interventions

Nicotine DRUG

6 mg experimental Nicotine Replacement Therapy (NRT)

Also known as: Not yet marketed

NRT 60; NRT 90

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• McNeil AB: lead

Study Sites (1)

McNeil AB Clinical Pharmacology R&D

Lund, SE-222 20, Sweden

Location

MeSH Terms

Conditions

Tobacco Use Disorder; Smoking Cessation

Interventions

Nicotine

Condition Hierarchy (Ancestors)

Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Solanaceous Alkaloids; Alkaloids; Heterocyclic Compounds; Pyridines; Heterocyclic Compounds, 1-Ring

Study Officials

• Elisabeth Kruse, PhD

  McNeil AB

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 24, 2011
• Study Start: February 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 10, 2012

Record last verified: 2012-07

Locations

SE (1)