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

This study has been completed.
Information provided by:
Novartis Identifier:
First received: August 7, 2008
Last updated: February 3, 2011
Last verified: February 2011
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 1

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
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

Resource links provided by NLM:

Further study details as provided by Novartis:

Primary Outcome Measures:
  • PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Assess the safety and tolerability, 3 weeks [ Designated as safety issue: Yes ]
  • Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks [ Designated as safety issue: No ]

Enrollment: 18
Study Start Date: July 2008
Primary Completion Date: August 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: fingolimod (FTY720)


Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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

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Please refer to this study by its identifier: NCT00731523

Russian Federation
Novartis Investigator Site
Moscow, Russian Federation
Sponsors and Collaborators
Principal Investigator: Novartis Novartis investigator site
  More Information

Responsible Party: External Affairs, Novartis Identifier: NCT00731523     History of Changes
Other Study ID Numbers: CFTY720D2108 
Study First Received: August 7, 2008
Last Updated: February 3, 2011
Health Authority: Russia: Ethics Committee

Keywords provided by Novartis:
FTY720, Pharmacokinetics, Renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Fingolimod Hydrochloride
Immunologic Factors
Immunosuppressive Agents
Physiological Effects of Drugs processed this record on May 25, 2016