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| Name | Class |
|---|---|
| Alkermes, Inc. | INDUSTRY |
This is a single site, double-blind, randomized, placebo-controlled, crossover study to assess the pharmacodynamics (PD) of RDC-0313 coadministered with buprenorphine in 12 healthy, opioid-experienced, non-treatment-seeking subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RDC-0313 + Buprenorphine | Active Comparator | Cohort 1 (1 and 4 mg) + 8 mg Cohort 2 (dependent on Cohort 1 results) |
|
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RDC-0313 + Buprenorphine | Drug | 1 and 4 mg (1 dose for each) + 8 mg |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacodynamics (PD) of study drug | 24 hour period | |
| VAS Scores | 24 Hours period | |
| Pupuillometry Assessments | 24 Hour Period | |
| Subjective Symptoms | 15 min pre and post nal, 3 hrs post bup admin |
| Measure | Description | Time Frame |
|---|---|---|
| To determine pharmacokinetics (PK) and evaluate safety and tolerability of study drug | 24 hour period | |
| Max plasma concentration | 24 Hour Period | |
| Time to maximum plasma concentration |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Langley Porter Psychiatric Hospital | San Francisco | California | 94143 | United States |
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| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| ID | Term |
|---|---|
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| C583425 | ALKS-33 |
| D002047 | Buprenorphine |
| ID | Term |
|---|---|
| D009019 | Morphinans |
| D053610 | Opiate Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
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| Placebo |
| Drug |
0 mg |
|
| 24 Hour Period |
| Area under the concentration time curve (AUC) | 24 Hour Period |
| Additional PK parameters may be analyzed | As appropriate |
| 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 |