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

• Sponsor: Novartis (Industry)
• Overall Status: Completed
• CT.gov ID: NCT00731523
• Collaborator: (none)
• Enrollment: 18
• Location: 1
• Arm: 1

Study Details

Study Description

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 better understanding of the effects of renal insufficiency on the disposition of FTY720.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency	Drug: fingolimod (FTY720)	Phase 1

Study Design

• Study Type: Interventional
• Actual Enrollment: 18 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Other
• 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
• Study Start Date: Jul 1, 2008
• Actual Primary Completion Date: Aug 1, 2008

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1	Drug: fingolimod (FTY720)

Outcome Measures

Primary Outcome Measures

1. PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks []

Secondary Outcome Measures

1. Assess the safety and tolerability, 3 weeks []

2. Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Locations

	Site	City	State	Country	Postal Code
1	Novartis Investigator Site	Moscow		Russian Federation

Sponsors and Collaborators

• Novartis

Investigators

• Principal Investigator: Novartis, Novartis investigator site

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

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

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00731523
• Other Study ID Numbers: CFTY720D2108
• First Posted: Aug 11, 2008
• Last Update Posted: Dec 9, 2020
• Last Verified: Feb 1, 2011

• Keywords provided by , ,: FTY720, Pharmacokinetics, Renal insufficiency
• Additional relevant MeSH terms: Renal Insufficiency; Fingolimod Hydrochloride

Study Results

No Results Posted as of Dec 9, 2020