Trials / Completed
CompletedNCT00731523
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
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
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 18 (actual)
- Sponsor
- Novartis · Industry
- Sex
- All
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Accepted
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
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | fingolimod (FTY720) |
Timeline
- Start date
- 2008-07-01
- Primary completion
- 2008-08-01
- First posted
- 2008-08-11
- Last updated
- 2020-12-09
Locations
1 site across 1 country: Russia
Source: ClinicalTrials.gov record NCT00731523. Inclusion in this directory is not an endorsement.