Naloxone Nasal Spray Pharmacokinetic Study

Mitovie Pharma

Status and phase: Unknown; Phase 1

Conditions: Opioid Overdose

Treatments: Drug: Naloxone hydrochloride solution for injection with mucosal atomization device; Drug: MVP005

Study type: Interventional

Funder types: Industry

Identifiers

NCT01622504

MVP005-CLN-001

Details and patient eligibility

About

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).

Full description

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.

Enrollment: 6 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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6 participants in 3 patient groups

Test Product Dose 1

Experimental group

Treatment:

Drug: MVP005

Drug: MVP005

Test Product Dose 2

Experimental group

Treatment:

Drug: MVP005

Drug: MVP005

Comparator Product

Active Comparator group

Treatment:

Drug: Naloxone hydrochloride solution for injection with mucosal atomization device