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

Purpose

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.

Condition	Intervention	Phase
Renal Insufficiency	Drug: fingolimod (FTY720)	Phase I

Drug Information available for:

FTY 720 Fingolimod

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Other, Open Label, Active Control, Single Group Assignment, Pharmacokinetics Study

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

Further study details as provided by Novartis:

Primary Outcome Measures:

PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks

Secondary Outcome Measures:

Assess the safety and tolerability, 3 weeks
Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks

Estimated Enrollment:	18
Study Start Date:	July 2008
Estimated Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental	Drug: fingolimod (FTY720)

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00731523

Contacts


Contact: Novartis	+41 61 324 1111

Locations


Russian Federation
	Novartis Investigator Site	Recruiting
	Moscow, Russian Federation
	Contact: Novartis +41 61 324 1111

Sponsors and Collaborators

Novartis

Investigators


Principal Investigator:	Novartis	Novartis investigator site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CFTY720D2108
First Received:	August 7, 2008
Last Updated:	August 8, 2008
ClinicalTrials.gov Identifier:	NCT00731523
Health Authority:	Russia: Ethics Committee

Keywords provided by Novartis:

FTY720, Pharmacokinetics, Renal insufficiency

Study placed in the following topic categories:

Renal Insufficiency

Urologic Diseases

FTY 720

Healthy

Kidney Diseases

Additional relevant MeSH terms:

Immunologic Factors

Physiological Effects of Drugs

Immunosuppressive Agents

Pharmacologic Actions

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00731523