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This study will be to compare the pharmacokinetics of nalmefene administration intranasal with and without an absorption enhancer compared to an intramuscular injection.
This study will be an inpatient, double-blind, randomized, crossover study involving 14 healthy volunteers. Each subject will receive 4 treatments during the 4 dosing periods.Subjects will stay in the inpatient facility for 17 days to complete the entire study and be discharged following completion of discharge procedures at the end of the last period. Subjects will be called 3 to 5 days after discharge to inquire concerning adverse events and concomitant medications since discharge. After obtaining informed consent, subject will be screened for eligibility. ON the day after clinic admission, subjects will be administered the intranasal-formulated drug in randomized order with 4 days between doses; the intramuscular dose will be administered during the fourth (last) treatment period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Nalmefene (high dose) | Experimental | Nalmefene (high dose) intranasal one time during the 17 day inpatient treatment period |
|
| Nalmefene and Intravail | Experimental | Nalmefene (high dose) with Intravail intranasal one time during the 17 day inpatient treatment period |
|
| Nalmefene (low dose) | Experimental | Nalmefene (low dose) intranasal one time during the 17 day inpatient treatment period |
|
| Nalmefene Intramuscular | Experimental | Nalmefene intramuscular one time during the 17 day inpatient treatment period |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nalmefene | Drug | Comparing pharmacokinetics of intranasal nalmefene to intramuscular nalmefene |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetic parameters of nalmefene | Maximum plasma concentration, time of Maximum observed concentration and area under the concentration-time curve | 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability | Measure by adverse events, vital signs, ECG, clinical laboratory changes and nasal irritation following the administration of nalmefene | 17 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Debra Kelsh, MD | Vince & Associates Clinical Research, Inc. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research | Overland Park | Kansas | 66212 | United States |
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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 |
|---|---|
| C038981 | nalmefene |
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