Status:
COMPLETED
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
Lead Sponsor:
Novartis
Conditions:
Renal Insufficiency
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
Brief 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 bette...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
18 Patients enrolled
Trial Details
Trial ID
NCT00731523
Start Date
July 1 2008
Last Update
December 9 2020
Active Locations (1)
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1
Novartis Investigator Site
Moscow, Russia