Naloxone Nasal Spray Pharmacokinetic Study

Phase 1

• Conditions: Opioid Overdose
• Interventions: Drug: MVP005; Drug: Naloxone hydrochloride solution for injection with mucosal atomization device

• Registration Number: NCT01622504
• Lead Sponsor: Mitovie Pharma Ltd

Brief Summary

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

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.

Study Timeline

• Status Verified: 2012-06
• Study Start: 2012-06
• Study First Submitted: 2012-06-13
• Study First Submitted QC: 2012-06-18
• Study First Posted: 2012-06-19
• Last Update Submitted: 2012-06-19
• Last Update Posted: 2012-06-20
• Primary Completion: 2012-07
• Study Completion: 2012-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 6

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Product Dose 1	MVP005	-
Test Product Dose 2	MVP005	-
Comparator Product	Naloxone hydrochloride solution for injection with mucosal atomization device	-

Primary Outcome Measures

Name	Time	Method
Pharmacokinetics	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	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)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

International Pharmaceutical Research Center (IPRC); 🇯🇴 Amman, Jordan