Naloxone Nasal Spray Pharmacokinetic Study

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2012 by Mitovie Pharma Ltd.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Mitovie Pharma Ltd
ClinicalTrials.gov Identifier:
NCT01622504
First received: June 13, 2012
Last updated: June 19, 2012
Last verified: June 2012
  Purpose

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).


Condition Intervention Phase
Opioid Overdose
Drug: MVP005
Drug: Naloxone hydrochloride solution for injection with mucosal atomization device
Phase 1

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

Resource links provided by NLM:


Further study details as provided by Mitovie Pharma Ltd:

Primary Outcome Measures:
  • Pharmacokinetics [ Time Frame: 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 ] [ Designated as safety issue: No ]
    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:
  • Number of subjects with adverse events [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose

  • Physical Examination [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Complete physical examination at screening and final follow-up and specific nasal examination post-dose

  • Vital signs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Vital signs at screening, final follow-up and pre- and post-dose

  • ECGs [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    ECGs at screening and final follow-up

  • Safety Laboratory Tests [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
    Haematology, biochemistry and urinalysis at screening and final follow-up


Estimated Enrollment: 6
Study Start Date: June 2012
Estimated Study Completion Date: August 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Test Product Dose 1 Drug: MVP005
2 mg single dose administered intranasally
Experimental: Test Product Dose 2 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

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01622504

Contacts
Contact: Rana Hassan, MSc +96265627651 r.hassan@iprc.com.jo
Contact: Halah Zqqout, BSc +96265627651 h.zqqout@iprc.com.jo

Locations
Jordan
International Pharmaceutical Research Center (IPRC) Not yet recruiting
Amman, Jordan
Contact: Rana Hassan, MSc    +96265627651    r.hassan@iprc.com.jo   
Contact: Halah Zqqout, BSc    +96265627651    h.zqqout@iprc.com.jo   
Principal Investigator: Abdullah Hiyari, MD         
Sponsors and Collaborators
Mitovie Pharma Ltd
Investigators
Principal Investigator: Abdullah Hiyari, MD IPRC, Jordan
  More Information

No publications provided

Responsible Party: Mitovie Pharma Ltd
ClinicalTrials.gov Identifier: NCT01622504     History of Changes
Other Study ID Numbers: MVP005-CLN-001
Study First Received: June 13, 2012
Last Updated: June 19, 2012
Health Authority: Jordan: Jordanian Food and Drug Administration

Keywords provided by Mitovie Pharma Ltd:
Intranasal
nasal spray
opioid
overdose

Additional relevant MeSH terms:
Pharmaceutical Solutions
Naloxone
Therapeutic Uses
Pharmacologic Actions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on September 18, 2014