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The purpose of this study is to compare the pharmacokinetics of FTY720 and its metabolites in patients with severe renal insufficiency and in matched, healthy volunteers. This study will allow a better understanding of the effects of renal insufficiency on the disposition of FTY720.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fingolimod (FTY720) | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the safety and tolerability, 3 weeks | ||
| Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks |
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Inclusion Criteria:
Healthy Subjects:
Severe Renal Impaired Patients:
Exclusion Criteria:
All Subjects/Patients:
Severe Renal Impaired Patients:
Other protocol-defined inclusion/exclusion criteria may apply
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| Name | Affiliation | Role |
|---|---|---|
| Novartis | Novartis investigator site | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigator Site | Moscow | Russia |
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| Label | URL |
|---|---|
| Results for CFTY720D2108 can be found on the Novartis Clinical Trials Results Website | View source |
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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 |
|---|---|
| D000068876 | Fingolimod Hydrochloride |
| ID | Term |
|---|---|
| D013110 | Sphingosine |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D011409 |
| Propylene Glycols |
| D006018 | Glycols |
| D000588 | Amines |