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A Drug-Drug Interaction study to assess the effects of EDP-235 on the Pharmacokinetics and Safety of midazolam, caffeine and rosuvastatin.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| EDP-235, midazolam, rosuvastatin and caffeine | Experimental | Subjects will receive EDP-235, midazolam, rosuvastatin and caffeine throughout the treatment period on respective dosing days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP-235 | Drug | Subjects will receive EDP-235 once daily on Days 5-15 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 | Up to 17 Days | |
| AUC of midazolam, caffeine, and rosuvastatin with and without the coadministration of EDP-235 | Up to 17 Days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events | Up to 22 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. | Salt Lake City | Utah | 84124 | United States |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000722008 | EDP-235 |
| D008874 | Midazolam |
| D000068718 | Rosuvastatin Calcium |
| D002110 | Caffeine |
| ID | Term |
|---|---|
| D001569 | Benzodiazepines |
| D001552 | Benzazepines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| Midazolam | Drug | Subjects will receive midazolam once daily on Days 1 and 12 |
|
| Rosuvastatin | Drug | Subjects will receive rosuvastatin once daily on Days 2 and 13 |
|
| Caffeine | Drug | Subjects will receive caffeine once daily on Days 1 and 12 |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006571 | Heterocyclic Compounds |
| D013449 | Sulfonamides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D005464 | Fluorobenzenes |
| D006845 | Hydrocarbons, Fluorinated |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D013450 | Sulfones |
| D013457 | Sulfur Compounds |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D014970 | Xanthines |
| D000470 | Alkaloids |
| D011688 | Purinones |
| D011687 | Purines |