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This Phase 1 open label study is being conducted to directly characterize the pharmacokinetic (PK) profiles of seladelpar following administration of a single oral dose in subjects with varying degrees of hepatic impairment (HI) compared to healthy matched control subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Normal | Experimental | Child-Pugh Score: N/A Subjects will receive a single 10 mg oral dose of seladelpar |
|
| Mild Impairment | Experimental | Child-Pugh Score: A (5 to 6 points) Subjects will receive a single 10 mg oral dose of seladelpar |
|
| Moderate Impairment | Experimental | Child-Pugh Score: B (7 to 9 points) Subjects will receive a single 10 mg oral dose of seladelpar |
|
| Severe Impairment | Experimental | Child-Pugh Score: C (10 to 15 points) Subjects will receive a single 10 mg oral dose of seladelpar |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| seladelpar | Drug | Oral single dose 10 mg |
|
| Measure | Description | Time Frame |
|---|---|---|
| Maximum plasma concentration (Cmax) | 5 days | |
| Time to reach maximum concentration (Tmax) | 5 days | |
| Area under of the curve (AUC0-t and AUC0-∞) | 5 days | |
| Elimination of half-life (t1/2) | 5 days | |
| Apparent terminal elimination rate constant (λz) | 5 days | |
| Total body clearance (CL/F) | 5 days | |
| Volume of distribution (Vz/F) | 5 days |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DaVita Clinical Research | Lakewood | Colorado | 80228 | United States | ||
| Orlando Clinical Research Center |
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| Orlando |
| Florida |
| 32809 |
| United States |
| DaVita Clinical Research | Minneapolis | Minnesota | 55404 | United States |
| Vrg & Noccr | Knoxville | Tennessee | 37920 | United States |
| ID | Term |
|---|---|
| C000713688 | seladelpar |
| C572244 | (2-methyl-4-(5-methyl-2-(4-trifluoromethyl-phenyl)-2H-(1,2,3)triazol-4-ylmethylsulfanyl)phenoxy)acetic acid |
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