Naloxone Nasal Spray Pharmacokinetic Study

Study Overview
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Brief Summary
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This study aims to compare the pharmacokinetics of naloxone when administered as the Mitovie nasal spray (Test Product) and as a solution for injection (Comparator Product) administered intranasally using a mucosal atomization device (MAD).

Detailed Description
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Naloxone hydrochloride is currently only recommended and licensed for intravenous, intramuscular and subcutaneous administration. It has also been used by intranasal administration (off-label use) when the intravenous route is not suitable by administering the Solution for Injection using a mucosal atomization device (MAD). However, due to the volume of naloxone solution administered this way, some of it may be inadvertently swallowed and not absorbed into the nasal mucosa and the product requires administration by medically trained personnel. The study aims to investigate intranasal administration of naloxone using a more concentrated solution and a nasal delivery device.

Official Title
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A Phase I Single Dose, Open Label, Randomized, Three Period Crossover Pilot Study to Compare the Pharmacokinetics, Safety and Tolerability of MVP005 Intranasal Spray With Intranasal Administration of Naloxone Solution for Injection in Healthy Adult Subjects

Conditions
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Opioid Overdose

Intervention / Treatment
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* Drug: MVP005
* Drug: MVP005
* Drug: Naloxone hydrochloride solution for injection with mucosal atomization device


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female 18-60 50 years of age Provide written informed consent prior to completing any study specific procedure. Body Mass Index (BMI) range 18.5-30 kg/m2 Clinically acceptable medical history, clinical laboratory evaluations, complete physical examination, vital signs and 12 lead ECG Using reliable contraception Exclusion Criteria: Intranasal problems Taking prescribed or over the counter medications Intake of alcohol, methyl-xanthines or grapefruit or strenuous exercise concurrent with treatment.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test Product Dose 1<br> | Drug: MVP005<br>* 2 mg single dose administered intranasally<br>|
| Experimental: Test Product Dose 2<br> | Drug: MVP005<br>* 4 mg single dose administered intranasally<br>|
| Active Comparator: Comparator Product<br> | Drug: Naloxone hydrochloride solution for injection with mucosal atomization device<br>* 2 mg single dose administered intranasally<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Plasma concentration time profiles and area under the curve (AUC), maximum concentation (Cmax), Time to maximum concentration (Tmax), elimination rate constant (Kel) and terminal half life (t1/2) | 0, 5, 10, 15, 20, 30 and 45 minutes and 1.00, 1.50, 2.00, 3.00, 4.00, 6.00, 8.00 and 12.00 hours for each arm | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects with adverse events | Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose | 14 days | 
| Physical Examination | Complete physical examination at screening and final follow-up and specific nasal examination post-dose | 14 days | 
| Vital signs | Vital signs at screening, final follow-up and pre- and post-dose | 14 days | 
| ECGs | ECGs at screening and final follow-up | 14 days | 
| Safety Laboratory Tests | Haematology, biochemistry and urinalysis at screening and final follow-up | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intranasal, nasal spray, opioid, overdose