Single-Dose Bioequivalence Study Comparing Two 2 mg Nicotine Lozenges

NCT03432273 | Completed Phase 1

• 1 other identifier: F-ZA113
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between a new nicotine lozenge and a reference nicotine lozenge in healthy smokers.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (2)

• Cmax

  Maximum observed plasma concentration (Cmax)

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

• AUC0-t

  Area under the plasma concentration versus time curve, from time zero to t, where t is the time of the last quantifiable concentration (AUC0-t)

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

Secondary Outcomes (5)

• Tmax

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

• AUC0-inf

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

• λz

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

• t½.z

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

• kel

  Blood samples taken pre-dose and post-dose at 5, 10, 20, 30, 40, and 50 minutes, and 1, 1.25, 1.5, 2, 3, 6, 9, 12, 16 and 24 hours

Study Arms (2)

Nicotine 2 mg mint lozenges

EXPERIMENTAL

Drug: Nicotine lozenge

NiQuitin 2 mg mint lozenges

ACTIVE COMPARATOR

Drug: Nicotine lozenge

Interventions

Nicotine lozenge DRUG

Nicotine mint lozenge, 2 mg

Nicotine 2 mg mint lozenges

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Written consent given for participation in the study.
• Healthy males and females, 18 to 55 years (inclusive) at screening.
• Body Mass Index (BMI) between 18.5 and 30 kg/m2 (both inclusive).
• Body mass not less than 50 kg.
• Medical history, vital signs, physical examination, standard 12-lead electrocardiogram (ECG) and laboratory investigations must be clinically acceptable or within laboratory reference ranges for the relevant laboratory tests, unless the investigator considers the deviation to be irrelevant for the purpose of the study.
• Females, if:
• Not of childbearing potential, e.g., has been surgically sterilized, undergone a hysterectomy, amenorrhea for ≥ 12 months and considered post-menopausal, Note: in postmenopausal women, the value of the serum pregnancy test may be slightly increased. This test will be repeated to confirm the results. If there is no increase indicative of pregnancy, the female will be included in the study.
• Of childbearing potential, the following conditions are to be met:
• Negative pregnancy test
• If this test is positive, the subject will be excluded from the study. In the rare circumstance that a pregnancy is discovered after the subject received IMP, every attempt must be made to follow her to term.
• Not lactating
• Abstaining from sexual activity (if this is the usual lifestyle of the subject) or must agree to use an accepted method of contraception, and agree to continue with the same method throughout the study Examples of reliable methods of contraception include oral (documented that the dose has been stable for at least one month before the first intake of IMP), injectable or implantable contraceptives and non-hormonal intrauterine device.
• In this study the concomitant use of hormonal contraceptives is allowed. Other methods, if considered by the investigator as reliable, will be accepted.
• History of cigarette smoking of at least 10 cigarettes per day continuously for the past 3 months prior to screening and smokes first cigarette in more than 30 minutes after waking up in the morning.
• No use of any tobacco or nicotine-containing products within 21 days of the first dose except cigarettes.

You may not qualify if:

• Evidence of psychiatric disorder, antagonistic personality, poor motivation, emotional or intellectual problems likely to limit the validity of consent to participate in the study or limit the ability to comply with protocol requirements.
• Any surgical or medical condition which may significantly alter the absorption, distribution, metabolism or excretion of any IMP substance.
• Current alcohol use \> 21 units of alcohol per week for males and \> 14 units of alcohol per week for females or evidence of excessive alcohol use as indicated by an alcohol breathalyzer test result ≥ 0.01%.
• Regular exposure to substances of abuse (other than alcohol) within the past year.
• Use of any medication, prescribed or over-the-counter or herbal remedies, within 2 weeks before the first administration of IMP except if this will not affect the outcome of the study in the opinion of the investigator.
• In this study the concomitant use of hormonal contraceptives is allowed.
• Expired CO levels greater than 10 ppm in the morning prior to dosing.
• History of esophagitis, gastritis, peptic ulcer, gastro-esophageal reflux, gastrointestinal bleeding, rectal bleeding or other clinically significant gastrointestinal abnormalities within past 3 months.
• History of cardiovascular disease such as uncontrolled hypertension, myocardial infarction, stroke or transient ischemic attack within the past 6 months prior to screening, congestive heart failure, angina pectoris, and arrhythmia.
• Evidence of vasospastic disease (i.e., Buerger's disease) on medical history and physical examination.
• Unable or unwilling to abstain from methylxanthines for 72 hours pre-dose.
• Participation in another study with an experimental drug, where the last administration of the previous IMP was within 8 weeks (or within 5 elimination half-lives for chemical entities or 2 elimination half-lives for antibodies or insulin, whichever is the longer) before administration of IMP in this study, at the discretion of the investigator.
• Treatment within the previous 3 months before the first administration of IMP with any drug with a well-defined potential for adversely affecting a major organ or system.
• A major illness during the 3 months before commencement of the screening period.
• History of hypersensitivity or allergy to the IMP or its excipients or any related medication.

Sponsors & Collaborators

• Fertin Pharma A/S: lead

Study Sites (1)

Bloemfontein Early Phase Clinical Unit, PAREXEL International (South Africa)

Bloemfontein, 9301, South Africa

Location

MeSH Terms

Conditions

Smoking Cessation

Interventions

Tobacco Use Cessation Devices

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Yolandi Swart, Dr.

  PAREXEL (South Africa)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 1, 2018
• First Posted: February 14, 2018
• Study Start: February 19, 2018
• Primary Completion: March 27, 2018
• Study Completion: March 27, 2018
• Last Updated: August 9, 2018

Record last verified: 2018-08

Locations

ZA (1)