Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
NCT00731523 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 18
Last updated 2020-12-09
Summary
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.
Conditions
- Renal Insufficiency
Interventions
- DRUG
-
fingolimod (FTY720)
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Novartis · Novartis investigator site
Study Design
- Allocation
- NA
- Purpose
- OTHER
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Max Age
- 65 Years
- Sex
- ALL
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2008-07-31
- Primary Completion
- 2008-08-31
Countries
- Russia
Study Locations
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