Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Vince & Associates Clinical Research, Inc. | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
To determine the pharmacokinetics of 4 intranasal doses of naloxone compared to a 0.4 mg dose of naloxone administrated intramuscular and to identify an appropriate intranasal dose that could achieve systemic exposure comparable to an approved parenteral dose. To also determine the pharmacokinetics of two different concentrations of intranasal naloxone and finally, to determine the safety of intranasal naloxone with respect to nasal irritation.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 2mg Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 20 mg/mL formulation in one nostril |
|
| 4mg(a) Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 20 mg/mL formulation in both nostrils |
|
| 4mg(b) Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 40mg/mL formulation in one nostril |
|
| 8mg Intranasal Naloxone | Experimental | Administer 0.1mL spray of the 40mg/mL formulation in both nostrils |
|
| Intramuscular Naloxone | Experimental | Administer 1mL of 0.4mg/mL formulation intramuscularly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naloxone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum Plasma Concentration (Cmax) | Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration. | 720 minutes |
| Time at Maximum Plasma Concentration (Tmax) | Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration | 720 minutes |
| Area Under the Concentration (AUC 0-t) | Time curve from time zero to last measurable concentration. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration | 720 minutes |
| Area Under Curve (AUC 0-inf) | Time curve from time zero to infinity. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration | 720 minutes |
| Half-life | The apparent terminal exponential half-life. Measurement of serum naloxone prior to dosing and at times 2.5, 5, 10, 15, 20, 30, 45, 60, 120, 180, 240, 300, 360, 480 and 720 minutes after naloxone administration | 720 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events | will be reported from the start of the first session to the follow-up visit | minimum of 18 days |
| Vital Signs | Measured at pre-dose and at times 30 , 60, 120 and 480 minutes after naloxone administration. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
Not provided
| ID | Term |
|---|---|
| D062787 | Drug Overdose |
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D063487 | Prescription Drug Misuse |
| D000076064 | Drug Misuse |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
Not provided
Not provided
| ID | Term |
|---|---|
| D009270 | Naloxone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 480 minutes |
| 12-lead electrocardiogram | Measured at pre-dose and at times 60 and 480 minutes after naloxone administration. | 480 minutes |
| Nasal Irritation Scoring | Measured at pre-dose and at times 5, 30 , 60, 240 minutes and 24 hours after nasal naloxone administration. | 24 hours |
| D001523 | Mental Disorders |
| D000079524 | Narcotic-Related Disorders |
| D006572 |
| Heterocyclic Compounds, Bridged-Ring |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D010616 | Phenanthrenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |