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Naloxone Nasal Spray Pharmacokinetic Study

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified June 2012 by Mitovie Pharma Ltd.
Recruitment status was:  Not yet recruiting
Information provided by (Responsible Party):
Mitovie Pharma Ltd Identifier:
First received: June 13, 2012
Last updated: June 19, 2012
Last verified: June 2012
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
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 ]
    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 ]
    Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose

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

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

  • ECGs [ Time Frame: 14 days ]
    ECGs at screening and final follow-up

  • Safety Laboratory Tests [ Time Frame: 14 days ]
    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.

Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

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 identifier: NCT01622504

Contact: Rana Hassan, MSc +96265627651
Contact: Halah Zqqout, BSc +96265627651

International Pharmaceutical Research Center (IPRC) Not yet recruiting
Amman, Jordan
Contact: Rana Hassan, MSc    +96265627651   
Contact: Halah Zqqout, BSc    +96265627651   
Principal Investigator: Abdullah Hiyari, MD         
Sponsors and Collaborators
Mitovie Pharma Ltd
Principal Investigator: Abdullah Hiyari, MD IPRC, Jordan
  More Information

Responsible Party: Mitovie Pharma Ltd Identifier: NCT01622504     History of Changes
Other Study ID Numbers: MVP005-CLN-001
Study First Received: June 13, 2012
Last Updated: June 19, 2012

Keywords provided by Mitovie Pharma Ltd:
nasal spray

Additional relevant MeSH terms:
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Pharmaceutical Solutions
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents processed this record on May 25, 2017