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Smoking CessationPhase 1NCT02356913

Comparison of Pharmacokinetic Profiles of 3 New Nicotine Gum Formulations With a Reference Gum

A Phase 1 study testing Nicotine gum in people with Smoking Cessation, run by Fertin Pharma A/S.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The purpose of the study is to compare the pharmacokinetic (PK) profiles and assess bioequivalence between three new nicotine gum formulations and a reference nicotine gum in healthy smokers. Read more about this study

Who is it for?
Ages 18 to 55 yearsHealthy volunteers can take part
Conditions the study is for
Smoking Cessation
What is being tested?
Nicotine gum
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
No sites listed yet
Study dates
Apr 2014to May 2014
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Healthy, adult, human smoker volunteers of any race within the age between 18 to 55 years.
  • Willingness to provide informed consent to participate in the study
  • Body Mass Index (BMI)> 18.5 kg/m2 to < 28.0 kg/m2.
  • Smoke 5-10 cigarettes per day continuously for the last three (3) months
  • Exhaled carbon monoxide ≥ 10 ppm at screening visit
  • Successfully complete the training session
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  • Medically healthy subjects with clinically normal laboratory profiles, vital signs and ECGs as deemed by the Clinical Investigator
  • Subject who are not in the process of quitting smoking
  • Hemoglobin: ≥12.0 gm% for male and ≥11.5 gm% for female
  • Absence of disease markers of HIV I \& II, HBsAg, HCVAb and P24 antigen test.
  • Females of childbearing age must be practicing an acceptable form of birth control for at least six months before screening and continue practicing an acceptable form of birth control during the study, unless they have had bilateral oophorectomy or tubal ligation or male partner has had vasectomy.
  • Females of childbearing age agree to use acceptable form of birth control until the drug is washed out from the body i.e. 3 days after last dosing, unless male partner has had vasectomy.
  • Absence of significant disease or clinically significant abnormal laboratory values on the laboratory evaluations, medical history or physical examination during the screening.
  • Have a normal 12-lead ECG or one with abnormality considered clinically insignificant.
  • Have a normal chest X-ray (P. A. view).
  • Comprehension of the nature and purpose of the study and willingness to comply with the requirements of the entire procedure.
  • Negative Breath alcohol test at every check in.
  • Negative serum β-HCG at the time of screening and at every check in (for females only).
  • Negative urine drug of abuse test (Barbiturates, Benzodiazepines, Opioids, Cocaine, Cannabinoids and Amphetamine, etc.) at every check-in. (This test will be done at the clinical facility).
  • Willing to use Nicotine chewing gum during the study

Who cannot join

  • History or presence of; drug abuse within the past year; hypersensitivity or idiosyncratic reaction to Nicotine or the resin of the gum preparation; any form of oral and/or pharyngeal inflammation; any form of oral lesions and/or gum disease or temperomandibular joint dysfunction; dentures or any dental work that could, in the opinion of the Investigator, affect the conduct of the study (including missing molars);
  • Any major illness in the last three months or any significant ongoing chronic medical illness.
  • History or presence of significant cardiovascular, pulmonary, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or psychiatric disease.
  • Active deep vein thrombosis, arterial thromboembolic disorders or a history of these conditions
  • History of or current gastro-intestinal diseases influencing drug absorption.
  • Subjects who had been on a special diet (for whatever reason) during the 28 days prior to the first dose and throughout the study.
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  • Those who have used tobacco or nicotine containing products within 24 hours prior to the study drug administration on each study day.
  • Subjects with carbon monoxide levels greater than or equal to 8 ppm in the morning prior to dosing.
  • Suffer from xerostomia (dry mouth).
  • Subjects using any smoking cessation aids such as nicotine replacement therapy (NRT), buproprion or varenicline during the last 3 months.
  • History of neuropsychiatric diseases.
  • History of breast cancer, endometrial cancer or other estrogen-dependent neoplasia, endometriosis and undiagnosed vaginal bleeding (for females only).
  • Consumption of xanthine containing food and beverages [chocolates, tea, coffee or cola drinks] less than 48.0 hours prior to check in.
  • Consumption of grapefruit/ Seville orange, grapefruit/ Seville orange juice products and poppy- containing food and beverages less than 48.0 hours prior to every check in.
  • History of alcoholism (more than two years), moderate drinkers (more than three drinks per day) or having consumed alcohol less than 48.0 hours prior to check in.
  • Participation in any clinical trial within last three months.
  • History of difficulty with donating blood or difficulty in accessibility of veins in left or right arm.
  • Donation of blood (one unit or 350 mL or more) within last three months prior to receiving the first dose of investigational products.
  • Use of any prescription drug therapy or over the counter (OTC) drugs or herbal products within two weeks prior to receiving the first dose of study medication and during the study [includes catecolamines, theophylline, clozapine and ropinirol].
  • Pregnant women
  • Breast feeding women

About this study

Official title: A Pilot, Open Label, Randomised, Single Dose, Four-Period, Four-Treatment, Four-Sequence, Four Way Crossover Comparative Pharmacokinetic Study of Three Different 4 mg Nicotine Chewing Gum Test Formulations of Fertin Pharma A/S, Denmark With Nicorette Freshmint 4 mg Medicated Chewing Gum of McNeil Denmark ApS as Reference Formulation in Healthy, Adult, Human Smokers Under Fasting Conditions

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

Being tested
Nicotine gum
Medical subject headings
Smoking Cessation

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Nicotine gumDrug

Study groups in NCT02356913
Study groupRoleWhat they receive
Gum AExperimental4 mg nicotine gum; single dose; chewed 30 minutes
Receives: Drug: Nicotine gum
Gum BExperimental4 mg nicotine gum; single dose; chewed 30 minutes
Receives: Drug: Nicotine gum
Gum CExperimental4 mg nicotine gum; single dose; chewed 30 minutes
Receives: Drug: Nicotine gum
Nicorette FreshmintActive comparator4 mg nicotine gum; single dose; chewed 30 minutes
Receives: Drug: Nicotine gum

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The maximum observed nicotine concentration in plasma (Cmax)

    Measured: 12 hours

  2. The area under the plasma concentration vs. time curve until the last measurable concentration (AUC0-t)

    Measured: 12 hours

  3. The area under the plasma concentration vs. time curve until infinity (AUC∞)

    Measured: 12 hours

Secondary outcomes (4)

  1. Tmax

    The time of occurrence of Cmax following product administration

    Measured: 12 hours from start of product administration

  2. Kel

    The apparent Terminal Elimination Rate Constant of nicotine

    Measured: 12 hours

  3. T½

    The apparent Terminal Elimination Half-life of nicotine

    Measured: 12 hours

  4. The amount of nicotine released from the gum during 30 minutes of chewing

    Measured: 30 minutes

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2015 (estimated)
  2. Study startApr 2014
  3. Primary completionMay 2014
  4. Study completionMay 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
15 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02356913
Sponsor's protocol ID
F-IN112
Other IDs
NIC/2013/1012
Status last verified
Feb 2015
First submitted
2 Feb 2015
Last updated
5 Feb 2015
Results posted
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nicotine gum in people with Smoking Cessation, run by Fertin Pharma A/S.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The maximum observed nicotine concentration in plasma (Cmax) (time frame: 12 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02356913.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2015.

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