A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Powder

NCT04713709 | Completed Phase 1 FDA Drug FDA Device

• 1 other identifier: NP-NAL-004
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Opioid Overdose

Keywords

Naloxone; Nasal; Powder

Outcome Measures

Primary Outcomes (5)

• Unconjugated naloxone in plasma - Cmax

  Pharmacokinetic Parameters

  0 to 8 hours post dose

• Unconjugated naloxone in plasma - AUC

  Pharmacokinetic Parameters

  0 to 8 hours post dose

• Unconjugated naloxone in plasma - Tmax

  Pharmacokinetic Parameters

  0 to 8 hours post dose

• Unconjugated naloxone in plasma - K el

  Pharmacokinetic Parameters

  0 to 8 hours post dose

• Unconjugated naloxone in plasma- T half

  Pharmacokinetic Parameters

  0 to 8 hours post dose

Secondary Outcomes (20)

• Blood pressure

  pre-dose

• Pulse

  pre-dose

• Blood pressure

  1 hour post dose

• Pulse

  1 hour post dose

• Blood pressure

  2 hour post dose

Study Arms (2)

FMXIN001 4 mg Naloxone microspheres powder,

EXPERIMENTAL

Naloxone powder nasal spray from Nasus Pharma, Israel

Combination Product: Nasus Pharma FMXIN001; Combination Product: Nasal Naloxone liquid spray

Narcan® 4 mg/0.1 mL nasal spray

ACTIVE COMPARATOR

Naloxone solution nasal spray from Adapt Pharma, Inc., USA

Combination Product: Nasus Pharma FMXIN001; Combination Product: Nasal Naloxone liquid spray

Interventions

Nasus Pharma FMXIN001 COMBINATION_PRODUCT

A nasal spray of 4mg Naloxone Hydrochloride powder in a unit dose device

FMXIN001 4 mg Naloxone microspheres powder,; Narcan® 4 mg/0.1 mL nasal spray

Nasal Naloxone liquid spray COMBINATION_PRODUCT

A nasal spray of 4mg/0.1mL Naloxone Hydrochloride solution in a unit dose device

Also known as: Narcan

FMXIN001 4 mg Naloxone microspheres powder,; Narcan® 4 mg/0.1 mL nasal spray

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy, non-smoking, male and female subjects, 18 years of age or older.
• BMI ≥18 and ≤30 kg/m2.
• 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).
• Willing to use acceptable, effective methods of contraception.
• Able to tolerate venipuncture.
• Be informed of the nature of the study and give written consent prior to any study procedure.

You may not qualify if:

• 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.
• Known or suspected carcinoma.
• Known history or presence of hypersensitivity or idiosyncratic reaction to naloxone or any other drug substances with similar activity.
• Known history or presence of clinically significant lactose, galactose, or fructose intolerance.
• Presence of hepatic or renal dysfunction.
• Presence of nostril or septum piercing.
• Presence of abnormal nasal anatomy.
• Presence of hay fever/seasonal allergy/rhinitis.
• Presence of sinusitis.
• Presence of nasal symptoms (e.g., blocked and/or runny nose, nasal polyps).
• Presence of nasal septum ulcers or perforations, or nasal trauma within 30 days prior to drug administration.
• History of nasal surgery.
• History of malabsorption within the last year or presence of clinically significant gastrointestinal disease.
• History of atopic allergy (e.g., asthma, urticaria, eczematous dermatitis).
• Presence of a medical condition requiring regular medication (prescription and/or over-the-counter) with systemic absorption.

Sponsors & Collaborators

• Nasus Pharma: lead

Study Sites (1)

Pharma Medica Research Inc

Mississauga, Ontario, L5R 0B7, Canada

Location

Related Publications (1)

• Lapidot T, Bouhajib M, Faulknor J, Khan S, Krayz GT, Abrutzky C, Megiddo D. A Novel Faster-Acting, Dry Powder-Based, Naloxone Intranasal Formulation for Opioid Overdose. Pharm Res. 2022 May;39(5):963-975. doi: 10.1007/s11095-022-03247-5. Epub 2022 Apr 6.

  PMID: 35386013 RESULT

Related Links

• Lapidot, Tair, et al. "A Novel Faster-Acting, Dry Powder-Based, Naloxone Intranasal Formulation for Opioid Overdose." Pharmaceutical Research (2022): 1-13.

MeSH Terms

Conditions

Opiate Overdose

Interventions

Naloxone

Condition Hierarchy (Ancestors)

Drug Overdose; Prescription Drug Misuse; Drug Misuse; Substance-Related Disorders; Chemically-Induced Disorders; Opioid-Related Disorders; Narcotic-Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Officials

• Janice Faulknor, MD, CCFP

  Pharma Medica Research Inc. Canada

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Open-label, single-dose, randomized, two-period, two treatment, two-sequence, crossover, comparative bioavailability study

Study Record Dates

• First Submitted: January 11, 2021
• First Posted: January 19, 2021
• Study Start: January 31, 2021
• Primary Completion: March 30, 2021
• Study Completion: October 10, 2021
• Last Updated: May 2, 2022

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)