Multiple-dose Nicotine Pharmacokinetics With Three Oral Nicotine Replacement Products

Phase 1CompletedNCT01321931

McNeil AB50 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Tobacco Dependence

Interventions

NicotineDRUG

6 mg experimental Nicotine Replacement Therapy (NRT)

NicotineDRUG

4 mg marketed Nicotine Fruit Gum (NFG)

NicotineDRUG

4 mg marketed nicotine mint lozenge (NIQ)

Eligibility

Sex: ALLMin age: 19 YearsMax age: 50 Years

Medical Language ↔ Plain English

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.

Locations (1)

McNeil AB Clinical Pharmacology R&D

Lund, Sweden

Outcomes

Primary Outcomes

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)

Time frame: 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

Time frame: 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)

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

Secondary Outcomes

Time of Maximum Concentration

The time at which maximum concentration is reached (Tmax)

Time frame: During 12 hours post-dose

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)

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

Peak-Trough Fluctuation

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)

Data from ClinicalTrials.gov

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