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A Non-Randomized, Open-Label, Drug-Drug Interaction Study to Evaluate the Effects of Fluconazole on the Pharmacokinetics and Safety of EDP-938 in Healthy Subjects
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-938 and Fluconazole interaction | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-938 | Drug | Subjects will receive EDP-938 once daily on Days 1 and 14 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-938 with and without coadministration with fluconazole | Up to 19 days | |
| AUC of EDP-938 with and without coadministration with fluconazole | Up to 19 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 25 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 |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc., | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D018357 | Respiratory Syncytial Virus Infections |
| ID | Term |
|---|---|
| D018186 | Pneumovirus Infections |
| D018184 | Paramyxoviridae Infections |
| D018701 | Mononegavirales Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| C000723099 | EDP-938 |
| D015725 | Fluconazole |
| ID | Term |
|---|---|
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
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| Fluconazole | Drug | Subjects will receive fluconazole once daily on Days 5 to 18 |
|
| D014777 | Virus Diseases |
| D007239 | Infections |