Opioid Overdose
Conditions
Keywords
Intranasal, nasal spray, opioid, overdose
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).
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.
Interventions
DRUGMVP005
2 mg single dose administered intranasally
DRUGNaloxone hydrochloride solution for injection with mucosal atomization device
2 mg single dose administered intranasally
Sponsors
Mitovie Pharma Ltd
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of subjects with adverse events | 14 days | Continuous adverse event monitoring during the study with prompted assessments in the 12 hours post-dose |
| Physical Examination | 14 days | Complete physical examination at screening and final follow-up and specific nasal examination post-dose |
| Vital signs | 14 days | Vital signs at screening, final follow-up and pre- and post-dose |
| ECGs | 14 days | ECGs at screening and final follow-up |
| Safety Laboratory Tests | 14 days | Haematology, biochemistry and urinalysis at screening and final follow-up |
Countries
Jordan
Contacts
Primary ContactRana Hassan, MSc
Backup ContactHalah Zqqout, BSc
Outcome results
None listed