AzTrials
AzTrials

Opioid OverdosePhase 1NCT04713709

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

A Phase 1 study testing Nasus Pharma FMXIN001 and Nasal Naloxone liquid spray in people with Opioid Overdose, run by Nasus Pharma at 1 site in Canada.

Completed

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

Official record
Search all trials

Trial summary

A Single-Dose, Bioequivalence Study of FMXIN001 4 mg Microspheres Nasal Powder. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Opioid Overdose
What is being tested?
Nasus Pharma FMXIN001 and Nasal Naloxone liquid spray
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteCanada
Study dates
31 Jan 2021to 10 Oct 2021
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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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:
Show all 11Show fewer
  • 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.

Who cannot join

  • The following exclusion criteria will be assessed at screening (within 28 days prior to the first drug administration):
  • 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.
Show all 41Show fewer
  • 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.
  • History of drug or alcohol addiction requiring treatment.
  • 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.
  • Positive test result for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
  • Positive test result for urine drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, phencyclidine, and tricyclic antidepressants) or urine cotinine.
  • Difficulty fasting or consuming standard meals.
  • Inability to communicate well with the Investigators and staff (i.e., language problem, poor mental development or impaired cerebral function).
  • Use of tobacco or nicotine-containing products within 6 months prior to drug administration.
  • 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.
  • 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.
  • 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.
  • On a special diet within 30 days prior to drug administration (e.g., liquid, protein, raw food diet).
  • Have had a tattoo or body piercing within 30 days prior to drug administration.
  • Have clinically significant findings in vital signs measurements.
  • 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.
  • Have clinically significant findings in a 12-lead ECG.
  • Have clinically significant abnormal laboratory values.
  • Have significant diseases.
  • Have clinically significant findings from a physical examination.
  • 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.

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Pharma Medica Research Inc

    Mississauga, Ontario, L5R 0B7

Other trials in Canada

About this study

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

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

Read the 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

Conditions
Opioid Overdose
Being tested
Nasus Pharma FMXIN001, Nasal Naloxone liquid spray
Keywords
Naloxone, Nasal, Powder
Medical subject headings
Opiate Overdose

What participants receive

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

  • Nasus Pharma FMXIN001Combination product

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

  • Nasal Naloxone liquid sprayCombination product

    Also called Narcan

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

Study groups in NCT04713709
Study groupRoleWhat they receive
FMXIN001 4 mg Naloxone microspheres powder,ExperimentalNaloxone powder nasal spray from Nasus Pharma, Israel
Receives: Combination Product: Nasus Pharma FMXIN001; Combination Product: Nasal Naloxone liquid spray
Narcan® 4 mg/0.1 mL nasal sprayActive comparatorNaloxone solution nasal spray from Adapt Pharma, Inc., USA
Receives: Combination Product: Nasus Pharma FMXIN001; Combination Product: Nasal Naloxone liquid spray

What is being measured

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

  1. Unconjugated naloxone in plasma - Cmax

    Pharmacokinetic Parameters

    Measured: 0 to 8 hours post dose

  2. Unconjugated naloxone in plasma - AUC

    Pharmacokinetic Parameters

    Measured: 0 to 8 hours post dose

  3. Unconjugated naloxone in plasma - Tmax

    Pharmacokinetic Parameters

    Measured: 0 to 8 hours post dose

  4. Unconjugated naloxone in plasma - K el

    Pharmacokinetic Parameters

    Measured: 0 to 8 hours post dose

  5. Unconjugated naloxone in plasma- T half

    Pharmacokinetic Parameters

    Measured: 0 to 8 hours post dose

Secondary outcomes (20)

  1. Blood pressure

    Safety Monitoring: Vital signs

    Measured: pre-dose

  2. Pulse

    Safety Monitoring: Vital signs

    Measured: pre-dose

  3. Blood pressure

    Safety Monitoring: Vital signs

    Measured: 1 hour post dose

  4. Pulse

    Safety Monitoring: Vital signs

    Measured: 1 hour post dose

  5. Blood pressure

    Safety Monitoring: Vital signs

    Measured: 2 hour post dose

  6. Pulse

    Safety Monitoring: Vital signs

    Measured: 2 hour post dose

  7. Blood pressure

    Safety Monitoring: Vital signs

    Measured: 4 hour post dose

  8. Pulse

    Safety Monitoring: Vital signs

    Measured: 4 hour post dose

  9. Blood pressure

    Safety Monitoring: Vital signs

    Measured: 12 hour post dose

  10. Pulse

    Safety Monitoring: Vital signs

    Measured: 12 hour post dose

  11. 12-Lead ECG

    Safety Monitoring

    Measured: pre-dose

  12. 12-Lead ECG

    Safety Monitoring

    Measured: 0.5 hours

  13. 12-Lead ECG

    Safety Monitoring

    Measured: 2 hours

  14. 12-Lead ECG

    Safety Monitoring

    Measured: 12 hours

  15. 4-item NHANES Pocket Smell Test

    Safety Monitoring

    Measured: pre-dose

  16. 4-item NHANES Pocket Smell Test

    Safety Monitoring

    Measured: 24 hours post dose

  17. Nasal examination

    Safety Monitoring

    Measured: pre-dose

  18. Nasal examination

    Safety Monitoring

    Measured: 1 hour

  19. Nasal examination

    Safety Monitoring

    Measured: 23 hour

  20. Adverse events

    Safety Monitoring

    Measured: 0 to 24 hour post dose

Timeline

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

  1. First posted19 Jan 2021
  2. Study start31 Jan 2021
  3. Primary completion30 Mar 2021
  4. Study completion10 Oct 2021

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
Other
Allocation
Randomised
Intervention model
Crossover
Model description
Open-label, single-dose, randomized, two-period, two treatment, two-sequence, crossover, comparative bioavailability study
Masking
None (open label)
Enrolment
46 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04713709
Sponsor's protocol ID
NP-NAL-004
Status last verified
Apr 2022
First submitted
11 Jan 2021
Last updated
2 May 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • 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.

    PubMed 35386013

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Nasus Pharma FMXIN001 and Nasal Naloxone liquid spray in people with Opioid Overdose, run by Nasus Pharma at 1 site in Canada.

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 11 inclusion and 41 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 2 May 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Unconjugated naloxone in plasma - Cmax (time frame: 0 to 8 hours post dose). The study lists 5 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 NCT04713709, which also lists 1 linked publication.

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 2 May 2022; AzTrials last refreshed its copy on 7 Nov 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in