Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products.

Comparative Pharmacokinetic Study of New Oral Nicotine Replacement Therapy Products - A Study in Healthy Smokers.

Comparative pharmacokinetic study of new oral nicotine replacement therapy products.

Study Overview

• Status: Completed
• Conditions: Tobacco Dependence
• Intervention / Treatment: Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg; Drug: Marketed Nicotine Lozenge; Drug: Marketed Nicotine Lozenge; Drug: Experimental Nicotine Replacement Therapy (NRT)

Detailed Description

This study compares new oral Nicotine Replacement Therapy (NRT) products containing 2 and 4 mg nicotine with NiQuitin™ lozenge 2 mg and 4 mg, after 12 hours of nicotine abstinence, with respect to nicotine pharmacokinetics, during 12 hours after start of administration. Single doses of treatment A, B, C, and D are given once in the morning during separate treatment visits scheduled in a crossover setting with randomized treatment sequences, also including a fifth treatment visit with either treatment E or F. The study will include 104 healthy smokers between the ages of 19 and 50 years, who have been smoking at least 10 cigarettes daily during at least one year preceding inclusion. The study will be performed at two sites with 52 subjects at each site. Subjects and study personnel will be aware of which treatment is administered at a given visit.

• Study Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Sweden
  • Lund, Sweden, SE-222 20
    • McNeil AB Clinical Pharmacology R&D
  • Lund, Sweden, SE-221 85
    • Lund University Hospital Clinical Trial Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 19 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Healthy subjects, smoking at least 10 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 month preceding the first dose of study medication.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A NSL2L; Experimental Nicotine Replacement Therapy (NRT)(L) 2 mg	Drug: Experimental Nicotine Replacement Therapy (NRT) 2 mg; 2 mg Single-dose of new NRT product (NSL2L); Other Names: Not yet marketed
Active Comparator: B Lozenge; Marketed Nicotine Lozenge 2 mg	Drug: Marketed Nicotine Lozenge; 2 mg Single-dose of marketed lozenge; Other Names: NiQuitin™ lozenge; Drug: Marketed Nicotine Lozenge; 4 mg Single-dose of marketed lozenge; Other Names: NiQuitin™ lozenge
Experimental: C NSL4M; Experimental NRT (M) 4 mg	Drug: Experimental Nicotine Replacement Therapy (NRT); 4 mg Single-dose of new NRT product; Other Names: Not yet marketed
Active Comparator: D Lozenge; Marketed Nicotine Lozenge 4 mg	Drug: Marketed Nicotine Lozenge; 2 mg Single-dose of marketed lozenge; Other Names: NiQuitin™ lozenge; Drug: Marketed Nicotine Lozenge; 4 mg Single-dose of marketed lozenge; Other Names: NiQuitin™ lozenge
Experimental: E NSL4L; Experimental NRT (L) 4 mg	Drug: Experimental Nicotine Replacement Therapy (NRT); 4 mg Single-dose of new NRT product; Other Names: Not yet marketed
Experimental: F NSL4H; Experimental NRT (H) 4 mg	Drug: Experimental Nicotine Replacement Therapy (NRT); 4 mg Single-dose of new NRT product; Other Names: Not yet marketed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Maximum Plasma Concentration	The maximum observed nicotine concentration in plasma (Cmax)	during 12 hours after product administration
Area under the Curve	The area under the plasma concentration-vs-time curve until the last measurable concentration (AUCt) and the area under the plasma concentration-vs.-time curve until infinity (AUC∞)	after 12 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time of Maximum Concentration	The time of occurrence of maximum concentration (Tmax)	during 12 hours after start of product administration
Terminal Elimination Rate Constant	The terminal nicotine elimination rate constant (λz)	during 12 hours after start of product administration
Oral Dissolution Time	Actual time required for oral dissolution	from administration until completely dissolved

Collaborators and Investigators

• Sponsor: McNeil AB

Study record dates

Study Major Dates

• Study Start: August 1, 2009
• Primary Completion (Actual): December 1, 2009
• Study Completion (Actual): January 1, 2010

Study Registration Dates

• First Submitted: October 22, 2010
• First Submitted That Met QC Criteria: October 22, 2010
• First Posted (Estimate): October 25, 2010

Study Record Updates

• Last Update Posted (Estimate): July 10, 2012
• Last Update Submitted That Met QC Criteria: July 6, 2012
• Last Verified: July 1, 2012

More Information

Terms related to this study

• Keywords: Smoking Cessation, Nicotine pharmacokinetics
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Tobacco Use Disorder; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Cholinergic Agents; Ganglionic Stimulants; Nicotinic Agonists; Cholinergic Agonists; Nicotine
• Other Study ID Numbers: NICTDP1076