Naloxone Nasal Spray Pharmacokinetic Study

Opioid Overdose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01622504
• Other study ID #: MVP005-CLN-001
• Status: Not yet recruiting
• Phase: Phase 1
• First received: June 13, 2012
• Last updated: June 19, 2012
• Start date: June 2012
• Est. completion date: August 2012

Study information

• Verified date: June 2012
• Source: Mitovie Pharma Ltd
• Contact: Rana Hassan, MSc
• Phone: +96265627651
• Email: r.hassan[@]iprc.com.jo
• Is FDA regulated: No
• Health authority: Jordan: Jordanian Food and Drug Administration
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 6
• Est. completion date: August 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Opioid Overdose

Intervention

Drug:
• MVP005
2 mg single dose administered intranasally
• MVP005
4 mg single dose administered intranasally
• Naloxone hydrochloride solution for injection with mucosal atomization device
2 mg single dose administered intranasally

Locations

Country	Name	City	State
Jordan	International Pharmaceutical Research Center (IPRC)	Amman

Sponsors (1)

Lead Sponsor	Collaborator
Mitovie Pharma Ltd

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Number of subjects with adverse events	Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose	14 days	Yes
Secondary	Physical Examination	Complete physical examination at screening and final follow-up and specific nasal examination post-dose	14 days	Yes
Secondary	Vital signs	Vital signs at screening, final follow-up and pre- and post-dose	14 days	Yes
Secondary	ECGs	ECGs at screening and final follow-up	14 days	Yes
Secondary	Safety Laboratory Tests	Haematology, biochemistry and urinalysis at screening and final follow-up	14 days	Yes