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

Renal Insufficiency Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00731523
• Other study ID #: CFTY720D2108
• Status: Completed
• Phase: Phase 1
• Start date: July 2008

Study information

• Verified date: February 2011
• Source: Novartis
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. primary completion date: August 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Renal Insufficiency

Intervention

Drug:
• fingolimod (FTY720)

Locations

Country	Name	City	State
Russian Federation	Novartis Investigator Site	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Novartis

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks
Secondary	Assess the safety and tolerability, 3 weeks
Secondary	Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks

External Links

•   Results for CFTY720D2108 can be found on the Novartis Clinical Trials Results Website