A Study of Fostamatinib in Subjects With Impaired Kidney Function - Full Text View

Purpose

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.

Condition	Intervention	Phase
Rheumatoid Arthritis Renal Impairment	Drug: fostamatinib	Phase 1

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Pharmacokinetics Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Basic Science
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

Resource links provided by NLM:

MedlinePlus related topics: Rheumatoid Arthritis

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Plasma pharmacokinetic (PK) parameters [ Designated as safety issue: No ]
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 [ Designated as safety issue: Yes ]
Urine PK parameters of R406 and its N-glucuronide metabolite [ Designated as safety issue: No ]
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 [ Designated as safety issue: No ]
PK parameters including, but not limited to, unbound AUC and unbound Cmaxt

Enrollment:	24
Study Start Date:	November 2010
Study Completion Date:	June 2011
Primary Completion Date:	June 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Healthy subjects (Stage 1)	Drug: fostamatinib Oral tablets, single dose
Experimental: 2 Mild renal impairment (Stage 2)	Drug: fostamatinib Oral tablets, single dose
Experimental: 3 Moderate renal impairment (Stage 2)	Drug: fostamatinib Oral tablets, single dose
Experimental: 4 Severe renal impairment (Stage 2)	Drug: fostamatinib Oral tablets, single dose
Experimental: 5 End stage renal disease (Stage 1)	Drug: fostamatinib Oral tablets, single dose

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01245790

Locations

United States, Florida
Research Site
Orlando, Florida, United States

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Mark Layton, MD	AstraZeneca
Principal Investigator:	Thomas Marbury, MD	Orlando Clinical

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier:	NCT01245790 History of Changes
Other Study ID Numbers:	D4300C00009
Study First Received:	November 19, 2010
Last Updated:	June 15, 2011
Health Authority:	United States: Food and Drug Administration United States: Institutional Review Board

Keywords provided by AstraZeneca:

Phase 1
healthy volunteers
volunteers with renal impairment
pharmacokinetics

Rheumatoid arthritis
RA
fostamatinib
Patients

Additional relevant MeSH terms:

Arthritis
Arthritis, Rheumatoid
Renal Insufficiency
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on May 23, 2013