Naloxone Nasal Spray Pharmacokinetic Study

This study is not yet open for participant recruitment.
Verified June 2012 by Mitovie Pharma Ltd
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

June 13, 2012
June 19, 2012
June 2012
July 2012   (final data collection date for primary outcome measure)
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)
Pharmacokinetics [ Time Frame: 12 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)
Complete list of historical versions of study NCT01622504 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
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).

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.

Interventional
Phase 1
Allocation: Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Opioid Overdose
  • Drug: MVP005
    2 mg single dose administered intranasally
  • Drug: MVP005
    4 mg single dose administered intranasally
  • Drug: Naloxone hydrochloride solution for injection with mucosal atomization device
    2 mg single dose administered intranasally
  • Experimental: Test Product Dose 1
    Intervention: Drug: MVP005
  • Experimental: Test Product Dose 2
    Intervention: Drug: MVP005
  • Active Comparator: Comparator Product
    Intervention: Drug: Naloxone hydrochloride solution for injection with mucosal atomization device
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
6
August 2012
July 2012   (final data collection date for primary outcome measure)

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.
Both
18 Years to 50 Years
Yes
Contact: Rana Hassan, MSc +96265627651 r.hassan@iprc.com.jo
Contact: Halah Zqqout, BSc +96265627651 h.zqqout@iprc.com.jo
Jordan
 
NCT01622504
MVP005-CLN-001
No
Mitovie Pharma Ltd
Mitovie Pharma Ltd
Not Provided
Principal Investigator: Abdullah Hiyari, MD IPRC, Jordan
Mitovie Pharma Ltd
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP