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This is a non-randomized, 2-part, open-label, drug-drug interaction (DDI) study to evaluate the effect of concomitant administration of itraconazole or rifampin on the pharmacokinetics and safety of EDP-305 in healthy human volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part 1 | Experimental |
| |
| Part 2 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| intraconazole | Drug | Subjects will receive itraconazole once daily from Day 5 through Day18 |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP-305 with and without coadministration with itraconazole | Up to 19 days | |
| AUC of EDP-305 with and without coadministration with itraconazole | Up to 19 days | |
| Cmax of EDP-305 with and without coadministration with rifampin | Up to 17 days | |
| AUC of EDP-305 with and without coadministration with rifampin | Up to 17 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measured by adverse events, physical exams, vital signs, 12-lead electrocardiograms (ECGs) and clinical lab results (including chemistry, hematology, and urinalysis). | Up to 19 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Ind | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pharmaceutical Research Associates, Inc., | Lenexa | Kansas | 66219 | 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 |
|---|---|
| D012293 | Rifampin |
| ID | Term |
|---|---|
| D012294 | Rifamycins |
| D006576 | Heterocyclic Compounds, 4 or More Rings |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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2-Part Single Group study.
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| Rifampin |
| Drug |
Subjects will receive rifampin once daily from Day 5 through Day 16 |
|
| EDP 305 | Drug | Subjects will receive EDP 305 once daily on Day 1 and Day 14 |
|
| D047029 | Lactams, Macrocyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |