Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
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.
|Study Design:||Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||An Open-label, Single-dose, Parallel-group Study to Compare the Pharmacokinetics of FTY720 and Metabolites in Subjects With Severe Renal Impairment With That in Matched Healthy Control Subjects|
- PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks [ Designated as safety issue: No ]
- Assess the safety and tolerability, 3 weeks [ Designated as safety issue: Yes ]
- Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks [ Designated as safety issue: No ]
|Study Start Date:||July 2008|
|Primary Completion Date:||August 2008 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00731523
|Novartis Investigator Site|
|Moscow, Russian Federation|
|Principal Investigator:||Novartis||Novartis investigator site|