Naloxone Nasal Spray Pharmacokinetic Study

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

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).

Study Overview

• Status: Unknown
• Conditions: Opioid Overdose
• Intervention / Treatment: Drug: MVP005; Drug: MVP005; Drug: Naloxone hydrochloride solution for injection with mucosal atomization device

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 Type: Interventional
• Enrollment (Anticipated): 6
• Phase: Phase 1

Contacts and Locations

• Study Contact: Name: Rana Hassan, MSc; Phone Number: +96265627651; Email: r.hassan@iprc.com.jo
• Study Contact Backup: Name: Halah Zqqout, BSc; Phone Number: +96265627651; Email: h.zqqout@iprc.com.jo

Study Locations

• Jordan
  • Amman, Jordan
    • International Pharmaceutical Research Center (IPRC)
    • Contact: Rana Hassan, MSc; Phone Number: +96265627651; Email: r.hassan@iprc.com.jo
    • Contact: Halah Zqqout, BSc; Phone Number: +96265627651; Email: h.zqqout@iprc.com.jo
    • Principal Investigator: Abdullah Hiyari, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mitovie Pharma Ltd
• Investigators: Principal Investigator: Abdullah Hiyari, MD, IPRC, Jordan

Study record dates

Study Major Dates

• Study Start: June 1, 2012
• Primary Completion (Anticipated): July 1, 2012
• Study Completion (Anticipated): August 1, 2012

Study Registration Dates

• First Submitted: June 13, 2012
• First Submitted That Met QC Criteria: June 18, 2012
• First Posted (Estimate): June 19, 2012

Study Record Updates

• Last Update Posted (Estimate): June 20, 2012
• Last Update Submitted That Met QC Criteria: June 19, 2012
• Last Verified: June 1, 2012

More Information

Terms related to this study

• Keywords: opioid; Intranasal; overdose; nasal spray
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders; Narcotic-Related Disorders; Opioid-Related Disorders; Drug Overdose; Opiate Overdose; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Naloxone
• Other Study ID Numbers: MVP005-CLN-001