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A Phase 1, Open-label Study of the absorption, metabolism, and excretion of a single oral dose of [14C]EDP-938 in healthy male subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single arm EDP-938 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-938 | Drug | [14C]EDP-938 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-938 in plasma | Up to 11 days | |
| AUC0-tlast of EDP-938 in plasma | Up to 11 days | |
| AUC-inf in plasma | Up to 11 days | |
| Amount excreted in urine (Aeu) | Up to 11 days | |
| Amount excreted in feces (Aef) | Up to 11 days | |
| Cmax of EDP-938 metabolites in plasma | Up to 11 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by occurrence of adverse events | Up to 11 days |
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Inclusion Criteria:
Exclusion Criteria:
Significant history or clinical manifestation of any metabolic, allergic, dermatological, hepatic, renal, hematological, pulmonary, cardiovascular, gastrointestinal, neurological, respiratory, endocrine, or psychiatric disorder, as determined by the investigator (or designee).
History of stomach or intestinal surgery or resection, including cholecystectomy, that would potentially alter absorption and/or excretion of orally administered drugs (uncomplicated appendectomy and hernia repair will be allowed).
a. Subjects with a history of cholecystitis, cholelithiasis, and/or choledocholithiasis will also be excluded.
Donation of blood from 3 months prior to screening, plasma from 2 weeks prior to screening, or platelets from 6 weeks prior to screening.
A body surface area-adjusted estimated glomerular filtration rate (eGFR) ≤ 90 mL/min per 1.73 m2 according to the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, at screening
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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 |
|---|---|
| C000723099 | EDP-938 |
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