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Lack of efficacy
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The purpose of this study is to compare and evaluate the pharmacokinetic characteristics and the safety of varespladib methyl in mild or moderate renal impairment patients and healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with mild renal impairment | Experimental |
| |
| Subjects with moderate renal impairment | Experimental |
| |
| Subjects with normal renal function | Experimental |
| |
| Subjects with severe renal impairment | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| varespladib methyl | Drug | Single oral 500 mg dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Measure of blood and urine levels of varespladib in subjects with renal impairment in comparison to subjects with normal renal function | PK samples will be collected predose and 0.5, 1, 1.5, 2, 3, 4, 6, 9, 12, 24, 48, and 72 hours postdose |
| Measure | Description | Time Frame |
|---|---|---|
| Safety measures to include adverse events and changes in clinical laboratory results | From admistration of study drug through follow-up on Day 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigator Site 101 | Orlando | Florida | 32809 | United States | ||
| Investigator Site 102 |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| ID | Term |
|---|---|
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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| ID | Term |
|---|---|
| C545088 | varespladib methyl |
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| Minneapolis |
| Minnesota |
| 55404 |
| United States |
| Investigator Site 103 | Knoxville | Tennessee | 37920 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |