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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00731523

Enrollment

Registered

2008-08-11

Start date

2008-07-31

Completion date

Unknown

Last updated

2020-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal Insufficiency

Keywords

FTY720, Pharmacokinetics, Renal insufficiency

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.

Interventions

DRUGfingolimod (FTY720)

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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/

Design outcomes

Primary

Measure	Time frame
PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks	—

Secondary

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

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026