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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Novartis
• Treatments: Fingolimod Hydrochloride

Criteria

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