Back to resultsPharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
Primary Purpose
Renal Insufficiency
Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
fingolimod (FTY720)
Sponsored by
About this trial
This is an interventional other trial for Renal Insufficiency focused on measuring FTY720, Pharmacokinetics, Renal insufficiency
Eligibility 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
Sites / Locations
- Novartis Investigator Site
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
Outcomes
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00731523
Brief Title
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
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 Type
Interventional
2. Study Status
Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
July 2008 (undefined)
Primary Completion Date
August 2008 (Actual)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Novartis
4. Oversight
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency
Keywords
FTY720, Pharmacokinetics, Renal insufficiency
7. Study Design
Primary Purpose
Other
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
fingolimod (FTY720)
Primary Outcome Measure Information:
Title
PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks
Secondary Outcome Measure Information:
Title
Assess the safety and tolerability, 3 weeks
Title
Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Novartis
Organizational Affiliation
Novartis investigator site
Official's Role
Principal Investigator
Facility Information:
Facility Name
Novartis Investigator Site
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Links:
URL
https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=2749
Description
Results for CFTY720D2108 can be found on the Novartis Clinical Trials Results Website
Learn more about this trial
Pharmacokinetics (PK) and Metabolism of FTY720 in Patients With Severe Renal Impairment and Healthy Matched Subjects.
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