Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Renal Insufficiency

Intervention / Treatment
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* Drug: fingolimod (FTY720)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy Subjects: Subjects must have a calculated glomerular filtration rate (GFR) by Cockcroft-Gault Equation ≥80 mL/min. Severe Renal Impaired Patients: Patients not on dialysis with severe renal failure with a creatinine clearance < 30 mL/min as determined by Cockcroft-Gault Equation. Renal function should have been stable within the 3 months prior to study start. Patients with diabetes and/or hypertension who are in otherwise in good health may be included. However patients with diabetes must not have clinical evidence of gastropathy or enteropathy. Exclusion Criteria: All Subjects/Patients: History of multiple and recurring allergies or allergy to the investigational compound/compound class being used in this study History of retinal macular edema. History of any significant cardiovascular events such as myocardia infarction, valvular disease, angina, ischemic heart disease, dilated cardiomyopathy, dysrhythmia. History of immunocompromise, including a positive HIV (ELISA and Western blot) test result. Severe Renal Impaired Patients: Use of any highly potent CYP3A4 inhibitor (e.g. erythromycin, ketoconazole, itraconazole) within 2 weeks prior to dosing. Use of beta blocker therapy within two (2) weeks prior to dosing. Other protocol-defined inclusion/exclusion criteria may apply

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: fingolimod (FTY720)<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | 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 |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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FTY720, Pharmacokinetics, Renal insufficiency