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A Study of Fostamatinib in Subjects With Impaired Kidney Function

Primary Purpose

Rheumatoid Arthritis, Renal Impairment

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

fostamatinib

About this trial

This is an interventional basic science trial for Rheumatoid Arthritis focused on measuring Phase 1, healthy volunteers, volunteers with renal impairment, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, Patients

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive
Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) < 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to < 80 mL/min; Moderate renal impairment ≥ 30 to <50 mL/min; and severe renal impairment 15 to < 30 mL/min
Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance >80 ml/min"
Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody

Exclusion Criteria:

Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration
Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L.
Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration
Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib
In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding

Sites / Locations

Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Arm Label

Arm Description

Healthy subjects (Stage 1)

Mild renal impairment (Stage 2)

Moderate renal impairment (Stage 2)

Severe renal impairment (Stage 2)

End stage renal disease (Stage 1)

Outcomes

Primary Outcome Measures

Plasma pharmacokinetic (PK) parameters

Parameters include: AUC, Cmax

Secondary Outcome Measures

Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms

Urine PK parameters of R406 and its N-glucuronide metabolite

PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr)

The effects of differences in protein binding by assessment of unbound R406 PK

PK parameters including, but not limited to, unbound AUC and unbound Cmaxt

Full Information

NCT ID

NCT01245790

First Posted

November 19, 2010

Last Updated

June 15, 2011

Sponsor

AstraZeneca

1. Study Identification

Unique Protocol Identification Number

NCT01245790

Brief Title

A Study of Fostamatinib in Subjects With Impaired Kidney Function

Official Title

An Open-label, Phase I Study to Assess the Pharmacokinetics of R406 in Subjects With Renal Impairment Compared to Healthy Subjects Following Administration of a Single Dose of Fostamatinib 150 mg

Study Type

Interventional

2. Study Status

Record Verification Date

June 2011

Overall Recruitment Status

Completed

Study Start Date

November 2010 (undefined)

Primary Completion Date

June 2011 (Actual)

Study Completion Date

June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

AstraZeneca

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

A 2 stage study to evaluate the amount of fostamatinib in the blood and urine in subjects with impaired kidney (renal) function compared with healthy volunteers with normal renal function. Stage 1 will include healthy subjects and subjects with end stage renal disease, while Stage, 2 may include subjects with mild, moderate and/or severe renal impairment dependent on the outcome of Stage 1. The study will also evaluate safety and tolerability in subjects with renal impairment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Rheumatoid Arthritis, Renal Impairment

Keywords

Phase 1, healthy volunteers, volunteers with renal impairment, pharmacokinetics, Rheumatoid arthritis, RA, fostamatinib, Patients

7. Study Design

Primary Purpose

Basic Science

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Healthy subjects (Stage 1)

Arm Title

Arm Type

Experimental

Arm Description

Mild renal impairment (Stage 2)

Arm Title

Arm Type

Experimental

Arm Description

Moderate renal impairment (Stage 2)

Arm Title

Arm Type

Experimental

Arm Description

Severe renal impairment (Stage 2)

Arm Title

Arm Type

Experimental

Arm Description

End stage renal disease (Stage 1)

Intervention Type

Drug

Intervention Name(s)

fostamatinib

Intervention Description

Oral tablets, single dose

Primary Outcome Measure Information:

Title

Plasma pharmacokinetic (PK) parameters

Description

Parameters include: AUC, Cmax

Secondary Outcome Measure Information:

Title

Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms

Title

Urine PK parameters of R406 and its N-glucuronide metabolite

Description

PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr)

Title

The effects of differences in protein binding by assessment of unbound R406 PK

Description

PK parameters including, but not limited to, unbound AUC and unbound Cmaxt

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Males or females (non child bearing potential) greater than or equal to 18 years of age with suitable veins for cannulation or repeated venipuncture and with a weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 40 kg/m2, inclusive Stable renal impairment with following creatinine clearance (CLCR): Stage 1 - End Stage Renal Disease (ESRD) < 15 mL/min (requiring dialysis); Stage 2 - Mild renal impairment ≥ 50 to < 80 mL/min; Moderate renal impairment ≥ 30 to <50 mL/min; and severe renal impairment 15 to < 30 mL/min Healthy subjects with normal renal function must have good health based on medical history, physical examination , echocardiogram and clinical laboratory evaluations including creatinine clearance >80 ml/min" Negative screen for Human Immunodeficiency Virus and negative results for serum hepatitis B surface antigen and hepatitis C antibody Exclusion Criteria: Subjects who have received any medications known to chronically alter drug absorption or elimination processes within 30 days of the first dose administration Absolute neutrophil count less than 1600/mm3 or 1.6 x 109 L. Healthy subjects only: Subjects who have received any prescribed systemic or topical medication within 14 days of the first dose administration Subjects with a history of multiple drug allergies or with a known allergy to the drug class of fostamatinib In the opinion of the Investigator, any evidence of additional severe or uncontrolled systemic disease (eg, currently unstable or uncompensated hepatic, cardiovascular, or respiratory disease) or laboratory finding

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mark Layton, MD

Organizational Affiliation

AstraZeneca

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Thomas Marbury, MD

Organizational Affiliation

Orlando Clinical

Official's Role

Principal Investigator

Facility Information:

Facility Name

Research Site

City

Orlando

State/Province

Florida

Country

United States

12. IPD Sharing Statement

Citations:

PubMed Identifier

26519231

Citation

Martin P, Oliver S, Gillen M, Marbury T, Millson D. Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2823-36. doi: 10.1016/j.clinthera.2015.09.016. Epub 2015 Oct 27.

Results Reference

derived

Links:

URL

http://www.studyforchange.com/

Description

Related Info

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A Study of Fostamatinib in Subjects With Impaired Kidney Function

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