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This study will be to determine the pharmacokinetics of naltrexone and naloxone when administered via intranasal separately and in combination in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Naltrexone | Experimental | Subject received a single intranasal dose of 2 mg naltrexone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered |
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| Naloxone | Experimental | Subject received a single intranasal dose of 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered |
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| Naltrexol | Experimental | Subject received a single intranasal dose of a combination of 2 mg naltrexone and 4 mg naloxone for a total of 3 times in a 13 day period with a 4-day washout period between each does until all treatments were administered |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Naltrexone | Drug | Intranasal spray |
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| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameter [maximum serum concentration - Cmax] | The primary endpoints of the study are the pharmacokinetic parameter, maximum serum concentration [Cmax], of naltrexone and naloxone when administered and in combination. | 12 days |
| Pharmacokinetic parameter [area under the plasma concentration time curve - AUCO-t] | The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration time curve [AUCO-t] of naltrexone and naloxone when administered and in combination. | 12 days |
| Pharmacokinetic parameter [area under the plasma concentration curve from zero to infinity - AUCO-inf] | The primary endpoints of the study are the pharmacokinetic parameter, area under the plasma concentration curve from zero to infinity [AUCO-inf] of naltrexone and naloxone when administered and in combination. | 12 days |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse Events | To assess and document any adverse events measures | 15 days |
| Vital Sign - Heart Rate | To assess and document heart rate before and after intranasal dosing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nora Chiang, PhD | NIH / NIDA | Study Chair |
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| ID | Term |
|---|---|
| D009293 | Opioid-Related Disorders |
| ID | Term |
|---|---|
| D000079524 | Narcotic-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D009271 | Naltrexone |
| C000624616 | vivitrol |
| D009270 | Naloxone |
| C010410 | 6 beta-hydroxynaltrexone |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Naloxone | Drug | Intranasal spray |
|
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| Naltrexol | Drug | Intranasal spray |
|
| 12 days |
| Vital Sign - Blood pressure (diastolic) | To assess and document blood pressure (diastolic) before and after intranasal dosing | 12 days |
| Vital Sign - Blood pressure (systolic) | To assess and document blood pressure (systolic) before and after intranasal dosing | 12 days |
| Vital Sign - Respiration Rate | To assess and document respiration rate before and after intranasal dosing | 12 days |
| Electrocardiogram | Twelve-lead ECGs performed according to standard procedures that will assess P wave, PR interval, QRS complex, ST segment, T wave and QT interval. | 12 days |
| 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 |