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| ID | Type | Description | Link |
|---|---|---|---|
| LX4211.121 | Other Identifier | Lexicon Pharmaceuticals, Inc. |
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The purpose of this study is to evaluate the effect of mild, moderate, or severe renal impairment, or end-stage renal disease (ESRD) requiring hemodialysis (HD), on the safety and tolerability of 1 or 2 single doses of sotagliflozin compared with healthy, demographically-matched subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects with normal renal function |
|
| Group 2 | Experimental | Subjects with mild renal impairment |
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| Group 3 | Experimental | Subjects with moderate renal impairment |
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| Group 4 | Experimental | Subjects with severe renal impairment |
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| Group 5 | Experimental | Subjects with ESRD requiring HD |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sotagliflozin | Drug | Single dose |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of treatment emergent adverse events | Day 1 to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Plasma concentration of sotaglifozin to evaluate AUC | Day 1 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Suman Wason, MD | Lexicon Pharmaceuticals, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Lexicon Investigational Site | Miami | Florida | 33014 | United States | ||
| Lexicon Investigational Site |
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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 |
|---|---|
| C575681 | (2S,3R,4R,5S,6R)-2-(4-chloro-3-(4-ethoxybenzyl)phenyl)-6-(methylthio)tetrahydro-2H-pyran-3,4,5-triol |
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| Sotagliflozin | Drug | 2 single doses |
|
| Orlando |
| Florida |
| 32809 |
| United States |
| Lexicon Investigational Site | Minneapolis | Minnesota | 55404 | United States |
| Lexicon Investigational Site | Saint Paul | Minnesota | 55114 | United States |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |