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

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ClinicalTrials.gov Identifier: NCT00731523
Recruitment Status : Completed
First Posted : August 11, 2008
Last Update Posted : February 4, 2011
Sponsor:
Information provided by:

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  (Clinical Trial)
Actual Enrollment : 18 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : July 2008
Primary Completion Date : August 2008

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00731523


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

Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00731523     History of Changes
Other Study ID Numbers: CFTY720D2108
First Posted: August 11, 2008    Key Record Dates
Last Update Posted: February 4, 2011
Last Verified: February 2011

Keywords provided by Novartis:
FTY720, Pharmacokinetics, Renal insufficiency

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases
Fingolimod Hydrochloride
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs