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Trial record 1 of 1 for:    Naloxone + Nasus | Canada
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A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder

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ClinicalTrials.gov Identifier: NCT04713709
Recruitment Status : Enrolling by invitation
First Posted : January 19, 2021
Last Update Posted : January 19, 2021
Sponsor:
Information provided by (Responsible Party):
Nasus Pharma

Brief Summary:
A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder.

Condition or disease Intervention/treatment Phase
Opioid Overdose Combination Product: Nasus Pharma FMXIN001 Combination Product: Nasal Naloxone liquid spray Phase 1

Detailed Description:
A comparison between FMXIN001 4 mg and Narcan® 4 mg/0.1 mL Nasal Spray under Fasting Conditions. A pharmacokinetic study in healthy volunteers

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: Open-label, single-dose, randomized, two-period, two treatment, two-sequence, crossover, comparative bioavailability study
Masking: None (Open Label)
Primary Purpose: Other
Official Title: A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder and Narcan® 4 mg/0.1 mL Nasal Spray Under Fasting Conditions
Estimated Study Start Date : January 31, 2021
Estimated Primary Completion Date : March 30, 2021
Estimated Study Completion Date : May 30, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: FMXIN001 4 mg Naloxone microspheres powder,
Naloxone powder nasal spray from Nasus Pharma, Israel
Combination Product: Nasus Pharma FMXIN001
A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device

Combination Product: Nasal Naloxone liquid spray
A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device
Other Name: Narcan

Active Comparator: Narcan® 4 mg/0.1 mL nasal spray
Naloxone solution nasal spray from Adapt Pharma, Inc., USA
Combination Product: Nasus Pharma FMXIN001
A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device

Combination Product: Nasal Naloxone liquid spray
A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device
Other Name: Narcan




Primary Outcome Measures :
  1. Unconjugated naloxone in plasma - Cmax [ Time Frame: 0 to 8 hours post dose ]
    Pharmacokinetic Parameters

  2. Unconjugated naloxone in plasma - AUC [ Time Frame: 0 to 8 hours post dose ]
    Pharmacokinetic Parameters

  3. Unconjugated naloxone in plasma - Tmax [ Time Frame: 0 to 8 hours post dose ]
    Pharmacokinetic Parameters

  4. Unconjugated naloxone in plasma - K el [ Time Frame: 0 to 8 hours post dose ]
    Pharmacokinetic Parameters

  5. Unconjugated naloxone in plasma- T half [ Time Frame: 0 to 8 hours post dose ]
    Pharmacokinetic Parameters


Secondary Outcome Measures :
  1. Blood pressure [ Time Frame: pre-dose ]
    Safety Monitoring: Vital signs

  2. Pulse [ Time Frame: pre-dose ]
    Safety Monitoring: Vital signs

  3. Blood pressure [ Time Frame: 1 hour post dose ]
    Safety Monitoring: Vital signs

  4. Pulse [ Time Frame: 1 hour post dose ]
    Safety Monitoring: Vital signs

  5. Blood pressure [ Time Frame: 2 hour post dose ]
    Safety Monitoring: Vital signs

  6. Pulse [ Time Frame: 2 hour post dose ]
    Safety Monitoring: Vital signs

  7. Blood pressure [ Time Frame: 4 hour post dose ]
    Safety Monitoring: Vital signs

  8. Pulse [ Time Frame: 4 hour post dose ]
    Safety Monitoring: Vital signs

  9. Blood pressure [ Time Frame: 12 hour post dose ]
    Safety Monitoring: Vital signs

  10. Pulse [ Time Frame: 12 hour post dose ]
    Safety Monitoring: Vital signs

  11. 12-Lead ECG [ Time Frame: pre-dose ]
    Safety Monitoring

  12. 12-Lead ECG [ Time Frame: 0.5 hours ]
    Safety Monitoring

  13. 12-Lead ECG [ Time Frame: 2 hours ]
    Safety Monitoring

  14. 12-Lead ECG [ Time Frame: 12 hours ]
    Safety Monitoring

  15. 4-item NHANES Pocket Smell Test [ Time Frame: pre-dose ]
    Safety Monitoring

  16. 4-item NHANES Pocket Smell Test [ Time Frame: 24 hours post dose ]
    Safety Monitoring

  17. Nasal examination [ Time Frame: pre-dose ]
    Safety Monitoring

  18. Nasal examination [ Time Frame: 1 hour ]
    Safety Monitoring

  19. Nasal examination [ Time Frame: 23 hour ]
    Safety Monitoring

  20. Adverse events [ Time Frame: 0 to 24 hour post dose ]
    Safety Monitoring



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Healthy, non-smoking, male and female subjects, 18 years of age or older.
  2. BMI ≥18 and ≤30 kg/m2.
  3. Females may be of childbearing or non-childbearing potential:

    • Childbearing potential:

      o Physically capable of becoming pregnant

    • Non-childbearing potential:

      • Surgically sterile (i.e., both ovaries removed, uterus removed, or bilateral tubal ligation); and/or
      • Postmenopausal (no menstrual period for at least 12 consecutive months without any other medical cause).
  4. Willing to use acceptable, effective methods of contraception.
  5. Able to tolerate venipuncture.
  6. Be informed of the nature of the study and give written consent prior to any study procedure.

Exclusion Criteria:

  • The following exclusion criteria will be assessed at screening (within 28 days prior to the first drug administration):

    1. Known history or presence of clinically significant neurologic, hematologic, endocrine, oncologic, pulmonary, immunologic, genitourinary, psychiatric, or cardiovascular disease or any other condition which, in the opinion of the Investigator, would jeopardize the safety of the subject or impact the validity of the study results.
    2. Known or suspected carcinoma.
    3. Known history or presence of hypersensitivity or idiosyncratic reaction to naloxone or any other drug substances with similar activity.
    4. Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
    5. Presence of hepatic or renal dysfunction.
    6. Presence of nostril or septum piercing.
    7. Presence of abnormal nasal anatomy.
    8. Presence of hay fever/seasonal allergy/rhinitis.
    9. Presence of sinusitis.
    10. Presence of nasal symptoms (e.g., blocked and/or runny nose, nasal polyps).
    11. Presence of nasal septum ulcers or perforations, or nasal trauma within 30 days prior to drug administration.
    12. History of nasal surgery.
    13. History of malabsorption within the last year or presence of clinically significant gastrointestinal disease.
    14. History of atopic allergy (e.g., asthma, urticaria, eczematous dermatitis).
    15. Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.
    16. History of drug or alcohol addiction requiring treatment.
    17. Any acute illness (e.g., cold/ rhinitis, acute infection) which is considered significant by the Investigator and that has not resolved within 7 days before the first drug administration.
    18. Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
    19. Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
    20. Difficulty fasting or consuming standard meals.
    21. Inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).
    22. Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
    23. Females who:

      • Have discontinued or changed the use of implanted, intrauterine, intravaginal, or injected hormonal contraceptives within 6 months prior to drug administration;
      • Have discontinued or changed the use of oral or patch hormonal contraceptives within 1 month prior to drug administration;
      • Are pregnant (serum hCG consistent with pregnancy); or
      • Are lactating.
    24. Donation or loss of whole blood (including clinical trials):

      • ≥50 mL and <500 mL within 30 days prior to drug administration;
      • ≥500 mL within 56 days prior to drug administration.
    25. Participation in a clinical trial that involved administration of an investigational medicinal product within 30 days prior to drug administration, or recent participation in a clinical investigation that, in the opinion of the Investigator, would jeopardize subject safety or the integrity of the study results.
    26. On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
    27. Have had a tattoo or body piercing within 30 days prior to drug administration.
    28. Have clinically significant findings in vital signs measurements.
    29. Systolic blood pressure increase or decrease in value by more than 20 mmHg and/or diastolic blood pressure decrease in value by more than 10 mmHg from supine or sitting to standing position.
    30. Have clinically significant findings in a 12-lead ECG.
    31. Have clinically significant abnormal laboratory values.
    32. Have significant diseases.
    33. Have clinically significant findings from a physical examination.
    34. Use of any enzyme-modifying drugs known to induce/inhibit hepatic drug metabolism or alter gastrointestinal pH/movement (e.g., omeprazole, ranitidine) within 30 days prior to drug administration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04713709


Locations
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Canada, Ontario
Pharma Medica Research Inc
Mississauga, Ontario, Canada, L5R 0B7
Sponsors and Collaborators
Nasus Pharma
Investigators
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Principal Investigator: Janice Faulknor, MD, CCFP Pharma Medica Research Inc. Canada
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Responsible Party: Nasus Pharma
ClinicalTrials.gov Identifier: NCT04713709    
Other Study ID Numbers: NP-NAL-004
First Posted: January 19, 2021    Key Record Dates
Last Update Posted: January 19, 2021
Last Verified: January 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Nasus Pharma:
Naloxone
Nasal
Powder
Additional relevant MeSH terms:
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Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents