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To Assess the Effect of Hepatic Impairment on the Pharmacokinetics of Bemnifosbuvir After a Single Dose
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 -Mild Hepatic Impairment | Experimental | Drug: single dose Bemnifosbuvir (BEM) |
|
| Group 2-Moderate Hepatic Impairment | Experimental | Drug: single dose Bemnifosbuvir (BEM) |
|
| Group 3 - Healthy Subjects matching mild and moderate impairment groups | Experimental | Drug: single dose Bemnifosbuvir (BEM) |
|
| Group 4 - Severe Hepatic Impairment | Experimental | Drug: single dose Bemnifosbuvir (BEM) |
|
| Group 5 - Normal hepatic function matching severe impairment group | Experimental | Drug: single dose Bemnifosbuvir (BEM) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bemnifosbuvir (BEM) | Drug | Day 1: A single dose of BEM will be administered |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics (PK) of BEM Maximum plasma concentration (Cmax) | Day 1 | |
| Pharmacokinetics (PK) of BEM Area under the plasma concentration-time curve (AUC) | Day 1 | |
| Pharmacokinetics (PK) of BEM AUC | Day 1 |
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Inclusion Criteria:
Subjects with Normal Hepatic Function (Groups 3 and 5):
Hepatic Impaired Subjects (Groups 1, 2, and 4):
Exclusion Criteria:
Hepatic Impaired Subjects (Groups 1, 2, and 4):
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Atea Study Site Orlando Clinical Research Center | Orlando | Florida | 32809 | United States |
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| ID | Term |
|---|---|
| C000713067 | AT-511 |
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