This study will be a Phase 1, single-center, open-label, randomized cross-over study to evaluate the PK of a new AP003 device which delivers two sprays of 4 mg naloxone hydrochloride intranasally.
Based on the intended AP003 product presentation there will be two devices in each carton allowing for administration of a total of 16 mg. This study is designed for subjects to receive naloxone therapy either through the AP003 device or through the currently approved NARCAN® nasal spray (4 mg) device (per label), reference therapy. After administration of the therapy patients will be followed by a 48-hour washout period before treatment crossover. Key study parameters include safety and PK. Safety evaluations will include but not limited to complete and system directed physical examinations (including signs of nasal irritation such as erythema, edema, and erosion), administration of a Brief Smell Identification Test (B-SIT), assessments of vital signs, 12 lead electrocardiogram (ECG), continuous cardiac telemetry monitoring (CCT) , clinical laboratory tests (e.g., hematology, chemistry, urinalysis, pregnancy test), and evaluation of adverse events.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
4 doses of 4 mg each (total: 16 mg) of naloxone through the AP003 device
2 doses of 4 mg each (total: 8 mg) of the naloxone through the NARCAN Nasal Spray device
Syneos Health Clinical Research Services
Miami, Florida, United States
Mean naloxone plasma concentration AP003 dosing periods.
The mean naloxone plasma concentration during the two AP003 dosing periods.
Time frame: PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours.
Mean naloxone plasma concentration Narcan dosing periods
The mean naloxone plasma concentration during the two Narcan dosing periods.
Time frame: PK samples taken at various timepoints over the course of Pre-dose and post-dose for 12 hours.
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE)
Incidence of treatment emergent adverse events (TEAEs), serious adverse events (SAE) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Time frame: Through end of study visit (within 7 days after second dose)
Incidence of abnormal vital signs
Incidence of abnormal vital signs (heart rate, blood pressure, and respiration rate) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Time frame: Through end of study visit (within 7 days after second dose)
Incidence of clinically significant ECG
Incidence of clinically significant ECG by treatment thru End of Study Visit (within 7 days after 2nd dose).
Time frame: Through end of study visit (within 7 days after second dose)
Incidence of clinical laboratory changes
Incidence of clinical laboratory changes by treatment thru End of Study Visit (within 7 days after 2nd dose).
Time frame: Through end of study visit (within 7 days after second dose)
Incidence of adverse events of special interest (AESI) indicating of nasal irritation
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Incidence of adverse events of special interest (AESI) indicating of nasal irritation (erythema, edema, and erosion) by treatment thru End of Study Visit (within 7 days after 2nd dose).
Time frame: Through end of study visit (within 7 days after second dose)
Incidence of changes in B-SIT assessment
Incidence of changes in B-SIT assessment within an AP003 period thru End of Study Visit (within 7 days after 2nd dose).
Time frame: Through end of study visit (within 7 days after second dose)