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The primary purpose of this study is to investigate the pharmacokinetics (behavior of the compound in the body) of safinamide in patients with different degrees of hepatic (liver) impairment in comparison to matched subjects with normal hepatic function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1 | Experimental | subjects with mild hepatic impairment |
|
| Arm 2 | Experimental | subjects with moderate hepatic impairment |
|
| Arm 3 | Experimental | matched subjects with normal hepatic function |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| safinamide | Drug | single dose of 50mg safinamide on Day 1 |
| |
| safinamide |
| Measure | Description | Time Frame |
|---|---|---|
| Pharmacokinetics of safinamide after single dose administration (Cmax) | 10 days | |
| Pharmacokinetics of safinamide after single dose administration (AUC) | 10 days |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and tolerability after single dose administration of safinamide (Adverse Events) | 12 days | |
| Pharmacokinetics of safinamide metabolite NW1153 (Cmax) | 10 days | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Atef Halabi, MD | CRS Clinical Research Services Kiel GmbH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CRS Clinical Research Services Kiel GmbH | Kiel | Germany |
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| ID | Term |
|---|---|
| D008107 | Liver Diseases |
| ID | Term |
|---|---|
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C092797 | safinamide |
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| Drug |
single dose of 50mg safinamide on Day 1 |
|
| safinamide | Drug | single dose of 50mg safinamide on Day 1 |
|
| Pharmacokinetics of safinamide metabolite NW1153 (AUC) |
| 10 days |
| Pharmacokinetics of safinamide metabolite NW1689 (Cmax) | 10 days |
| Pharmacokinetics of safinamide metabolite NW1689 (AUC) | 10 days |