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Naloxone Nasal Spray Pharmacokinetic Study

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ClinicalTrials.gov Identifier: NCT01622504
Recruitment Status : Unknown
Verified June 2012 by Mitovie Pharma Ltd.
Recruitment status was:  Not yet recruiting
First Posted : June 19, 2012
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
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).

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

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  (Clinical Trial)
Estimated Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (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
Study Start Date : June 2012
Estimated Primary Completion Date : July 2012
Estimated Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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 :
  1. 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

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

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

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

  5. Safety Laboratory Tests [ Time Frame: 14 days ]
    Haematology, biochemistry and urinalysis at screening and final follow-up



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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Mitovie Pharma Ltd
ClinicalTrials.gov Identifier: NCT01622504     History of Changes
Other Study ID Numbers: MVP005-CLN-001
First Posted: June 19, 2012    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Drug Overdose
Substance-Related Disorders
Chemically-Induced Disorders
Naloxone
Narcotic Antagonists
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents