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This is a study to characterize the pharmacokinetics as well as safety and tolerability of a single oral dose of EDP-305 in subjects with mild and moderate hepatic impairment compared to matched healthy subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mild hepatic impairment group | Experimental |
| |
| Moderate hepatic impairment group | Experimental |
| |
| Matching healthy control group | Experimental | Healthy control group will be matched with the hepatically impaired population with respect to age, sex and BMI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EDP 305 | Drug | Each subject will receive a single dose of EDP 305 on Day 1. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of EDP 305 | From pre-dose on Day 1 until 216 hour post-dose (Day 10) | |
| AUCinf of EDP 305 | From pre-dose on Day 1 until 216 hour post-dose (Day 10) | |
| t1/2 of EDP 305 | From pre-dose on Day 1 until 216 hour post-dose (Day 10) | |
| CL/F of EDP 305 | From pre-dose on Day 1 until 216 hour post-dose (Day 10) |
| 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). | From Screening up to Day 14 |
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Inclusion Criteria:
Additional criteria for hepatically impaired subjects
Exclusion Criteria:
Additional criteria for hepatically impaired Subjects
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| Name | Affiliation | Role |
|---|---|---|
| Enanta Pharmaceuticals, Inc | Enanta Pharmaceuticals, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Research Corporation at The Texas Liver Institute | San Antonio | Texas | 78215 | United States | ||
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| Pharmaceuticals Research Associates |
| Prague |
| Czechia |
| Summit SRO | Bratislava | Slovakia |