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The primary aim of the study is to assess the effect of itraconazole, carbamazepine, quinidine, and fluconazole individually on the pharmacokinetics and safety of EDP-323 in healthy adult participants. Each participant's duration in the study will be dependent upon which study part they are enrolled.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-323 and itraconazole interaction (Part 1) | Experimental | Subjects will receive EDP-323 and itraconazole on respective dosing days |
|
| EDP-323 and carbamazepine interaction (Part 2) | Experimental | Subjects will receive EDP-323 and carbamazepine on respective dosing days |
|
| EDP-323 and quinidine interaction (Part 3) | Experimental | Subjects will receive EDP-323 and quinidine on respective dosing days |
|
| EDP-323 and fluconazole interaction (Part 4) | Experimental | Subjects will receive EDP-323 and fluconazole on respective dosing days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-323 | Drug | Subjects will receive EDP-323 on Days 1 and 14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-323 with and without coadministration with Itraconazole | Day 1 through Day 19 | |
| AUC of EDP-323 with and without coadministration with Itraconazole | Day 1 through Day 19 | |
| Cmax of EDP-323 with and without coadministration with Carbamazepine | Day 1 through Day 28 | |
| AUC of EDP-323 with and without coadministration with Carbamazepine | Day 1 through Day 28 | |
| Cmax of EDP-323 with and without coadministration with Quinidine | Day 1 through Day 13 | |
| AUC of EDP-323 with and without coadministration with Quinidine | Day 1 through Day 13 | |
| Cmax of EDP-323 with and without coadministration with fluconazole | Day 1 through Day 19 | |
| AUC of EDP-323 with and without coadministration with fluconazole | Day 1 through Day 19 |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 34 Days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ICON, plc | San Antonio | Texas | 78209 | United States |
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| Itraconazole | Drug | Subjects will receive itraconazole QD Days 5-18 |
|
| EDP-323 | Drug | Subjects will receive EDP-323 on Days 1 and 23 |
|
| carbamazepine | Drug | Subjects will receive carbamazepine on Days 5 - 27 |
|
| EDP-323 | Drug | Subjects will receive EDP-323 on Days 1 and 8 |
|
| Quinidine | Drug | Subjects will receive quinidine on Days 5-12 |
|
| EDP-323 | Drug | Subjects will receive EDP-323 on Days 1 and 14 |
|
| fluconazole | Drug | Subjects will receive fluconazole on Days 5-18 |
|
| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D017964 | Itraconazole |
| D002220 | Carbamazepine |
| D011802 | Quinidine |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |
| D003984 | Dibenzazepines |
| D006575 | Heterocyclic Compounds, 3-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D002930 | Cinchona Alkaloids |
| D000470 | Alkaloids |
| D011812 | Quinuclidines |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
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