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

NCT00731523 | Completed Phase 1

• 1 other identifier: CFTY720D2108
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Renal Insufficiency

Keywords

FTY720, Pharmacokinetics, Renal insufficiency

Outcome Measures

Primary Outcomes (1)

• PK profile comparison between healthy volunteers and severe renal impaired patients, 3 weeks

Secondary Outcomes (2)

• Assess the safety and tolerability, 3 weeks

• Assess the influence of renal function on the pharmacokinetics of FTY720 metabolites M2 and M3, 3 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: fingolimod (FTY720)

Interventions

fingolimod (FTY720) DRUG

1

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis: lead

Study Sites (1)

Novartis Investigator Site

Moscow, Russia

Location

Related Links

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

MeSH Terms

Conditions

Renal Insufficiency

Interventions

Fingolimod Hydrochloride

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Intervention Hierarchy (Ancestors)

Sphingosine; Amino Alcohols; Alcohols; Organic Chemicals; Propylene Glycols; Glycols; Amines

Study Officials

• Novartis

  Novartis investigator site

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: August 7, 2008
• First Posted: August 11, 2008
• Study Start: July 1, 2008
• Primary Completion: August 1, 2008
• Last Updated: December 9, 2020

Record last verified: 2011-02

Locations

RU (1)