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The purpose of this study is to determine the effects of a potent CYP3A4 inhibitor, itraconazole, on the steady-state PK of AVP-923 and AVP-786.
A Phase 1, single-center, randomized, double-blind, double-dummy drug interaction study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1 - Period 1 | Experimental | AVP-923 and placebo matching AVP-786- BID Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
|
| Sequence 1 - Period 2 (after 3-week washout) | Experimental | AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
|
| Sequence 2 - Period 1 | Experimental | AVP-786 and placebo matching AVP-923 - BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
|
| Sequence 2 - Period 2 (after 3-week washout) | Experimental | AVP-923 and placebo matching AVP-786- BID on Day 1 until am of Day 15 Itraconazole - 200 mg BID on Day 9 followed by QD dosing on Days 10-15 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AVP-923 | Drug |
| ||
| AVP-786 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in plasma concentration of AVP-923 after dosing in combination with itraconazole | 16 Days | |
| Change in plasma concentration of AVP-786 after dosing in combination with itraconazole | 16 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of adverse events (AEs) for AVP-923 and itraconazole | 16 Days | |
| Incidence of adverse events (AEs) for AVP-786 and itraconazole | 16 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Vince and Associates Clinical Research, Inc. | Overland Park | Kansas | 66212 | United States |
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| Label | URL |
|---|---|
| Otsuka Clinical Trial Website | View source |
| Otsuka Clinical Trial Transparency | View source |
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| ID | Term |
|---|---|
| C507057 | dextromethorphan - quinidine combination |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Drug |
|
| Itraconazole | Drug |
|
|
| D010879 |
| Piperazines |