Pilot Pharmacokinetic Study of Investigational Sublingual Nicotine Tablet Versus COMMIT Nicotine Lozenge

NCT01887847 | Completed Phase 1

• 2 other identifiers: PPI 2006-01R41DA033710
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

The objective of this study is to compare the pharmacokinetics of an investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) to a 2 mg Commit® nicotine lozenge (GlaxoSmith Kline) in a randomized crossover design in 6 male and female otherwise healthy smokers.

Conditions

Nicotine Pharmacokinetic Study

Keywords

nicotine; pharmacokinetics

Outcome Measures

Primary Outcomes (1)

• The primary outcome measure is to substantiate that the pharmacokinetics of this novel nicotine replacement therapy (NRT) resembles that of smoking a cigarette, wherein the average Tmax is about 15 minutes or less. ►

  Serial blood samples will be obtained at the following times after the administration of the nicotine dosage forms: 0, 4, 8, 10, 12, 16, 30, 45, 60, 90, 120, and 180 minutes.

Secondary Outcomes (2)

• The secondary outcome is to compare craving scores for this investigational nicotine replacement therapy (NRT) to the lozenge.

  A craving questionnaire will be administered prior to dosing and at 5, 11, 17, 25, 35, 50, and 65 minutes and will then be administered every 30 minute thereafter up to 180 minute.

• A Product Preference Questionnaire

  At the end of the second dosing day.

Study Arms (2)

sublingual nicotine tablet

EXPERIMENTAL

investigational 2 mg sublingual nicotine tablet

Drug: Nicotine (Pharmaceutical Productions Inc.)

COMMIT nicotine lozenge

ACTIVE COMPARATOR

COMMIT 2 mg nicotine lozenge

Drug: Nicotine (Pharmaceutical Productions Inc.)

Interventions

Nicotine (Pharmaceutical Productions Inc.) DRUG

An investigational 2 mg sublingual nicotine tablet (Pharmaceutical Productions Inc.) will be administered in a randomized crossover design in 6 male and female otherwise healthy smokers.

Also known as: Investigational 2 mg sublingual nicotine tablet

sublingual nicotine tablet

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Subjects have to be 18-45 years old
• Subjects must provide written informed consent prior to any study related procedures being performed.
• Subjects must have a willingness and ability to comply with the protocol requirements.
• Subjects must be in good health and free from any clinically significant pathology (gastrointestinal tract, hepatic, renal, cardiovascular, central nervous system diseases)
• Subjects must have body mass index not to exceed 35
• Female subjects of childbearing potential, in addition to having a negative urine pregnancy test, must be willing to use a form of birth control during the study. The hormonal contraceptives should be avoided within 2 month prior to study entry.
• Subjects must consume more than 15 cigarettes daily and smoke their first cigarette within 30 minutes of awaking from sleeping.
• A Fagerstrom Smoking index greater than 4

You may not qualify if:

• Subjects that have used other nicotine delivery system such as nicotine lozenge, nicotine patch, nicotine inhaler, or nicotine nasal spray etc. within 30 days of study entry.
• Subjects who have smoked any substance other than tobacco within 30 days of study entry.
• Subjects that have used other smoking cessation aids (including bupropion, herbals, counseling, etc.) within 30 days of study entry.
• Subjects who have currently involved in another clinical trial or have used any investigational drug within 3 month of study entry.
• Subject who is pregnant or lactating, or planned to became pregnant within 6 months.
• Subjects who have diagnosed heart disease or are being treated with medication or had an irregular heartbeat or have had a heart attack.
• Subject with diagnosed stomach ulcers.
• Subjects who have taking insulin for diabetes.
• Subjects with high blood pressure not controlled by medication or a blood pressure greater than 150 mmHg systolic or 90 mmHg diastolic
• Subjects who are unable to fulfill study requirements in relation to conforming to the visit schedule.
• Subjects who have severe allergic history
• Subjects who have known intolerance to medication
• Subjects who have diagnosed chronic diseases of cardiovascular, pulmonary, neuro-endocrine systems, gastrointestinal, hepatic, renal, and blood diseases
• Subjects who had surgical operations on gastrointestinal tract with the exception of appendectomy
• Subjects who had acute infectious diseases within the last 4 weeks prior to the study entry;

Sponsors & Collaborators

• Pharmaceutical Productions Inc.: lead
• National Institute on Drug Abuse (NIDA): collaborator

Study Sites (1)

Friends Research Institute Clinic

Torrance, California, 90502, United States

Location

MeSH Terms

Interventions

Nicotine; Tobacco Use Cessation Devices

Intervention Hierarchy (Ancestors)

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

Study Officials

• Frank Vocci, Ph.D

  Friends Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: June 13, 2013
• First Posted: June 27, 2013
• Study Start: June 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: March 30, 2016

Record last verified: 2016-03

Locations

US (1)