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A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-305 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm EDP-305 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-305 | Drug | [14C]EDP-305 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-305 in plasma | Up to 9 days | |
| AUC of EDP-305 in plasma | Up to 9 days | |
| AUC-inf in plasma | Up to 9 days |
| Measure | Description | Time Frame |
|---|---|---|
| Amount excreted in urine (Aeu) | Up to 9 days | |
| Amount excreted in feces (Aef) | Up to 9 days | |
| Safety measured by adverse events |
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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 |
|---|---|---|---|---|---|---|
| Covance Clinical Research Unit | Madison | Wisconsin | 53704 | United States |
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| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000709367 | EDP-305 |
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| Up to 9 days |