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The primary purpose of the trial is to investigate the pharmacokinetics (behaviour of the compound in the body) of safinamide in subjects with different degrees of renal impairment in comparison to matched subjects with normal renal function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Subjects with moderate renal impairment |
|
| Group 2 | Experimental | Subjects with severe renal impairment |
|
| Group 3 | Experimental | Matched subjects with normal renal function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50mg safinamide | Drug | 50 mg safinamide on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide | 12 to 14 days | |
| AUC0-∞ of safinamide in plasma in groups of subjects with different grades of renal function after a single dose of 50 mg safinamide | 12 to 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Cmax of safinamide metabolite NW-1689 in plasma | 12 to 14 days | |
| Cmax of safinamide metabolite NW-1153 in plasma | 12 to 14 days | |
| Cmax of safinamide metabolite NW-1689 acylglucuronide in plasma |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Anne Marquet, PharmaD, PhD | Merck Serono S.A., Geneva | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | Schleswig-Holstein | Germany |
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| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D008224 | Lymphoma, Follicular |
| 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 |
|---|---|
| C092797 | safinamide |
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| 12 to 14 days |
| AUC0-∞ of safinamide metabolite NW-1689 in plasma | 12 to 14 days |
| AUC0-∞ of safinamide metabolite NW-1153 in plasma | 12 to 14 days |
| AUC0-∞ of safinamide metabolite NW-1689 acylglucuronide in plasma | 12 to 14 days |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |