A Study of Fostamatinib in Subjects With Impaired Kidney Function

NCT01245790 | Completed Phase 1

• 1 other identifier: D4300C00009
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Rheumatoid Arthritis; Renal Impairment

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Plasma pharmacokinetic (PK) parameters

  Parameters include: AUC, Cmax

Secondary Outcomes (3)

• 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

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

Study Arms (5)

1

EXPERIMENTAL

Healthy subjects (Stage 1)

Drug: fostamatinib

2

EXPERIMENTAL

Mild renal impairment (Stage 2)

Drug: fostamatinib

3

EXPERIMENTAL

Moderate renal impairment (Stage 2)

Drug: fostamatinib

4

EXPERIMENTAL

Severe renal impairment (Stage 2)

Drug: fostamatinib

5

EXPERIMENTAL

End stage renal disease (Stage 1)

Drug: fostamatinib

Interventions

fostamatinib DRUG

Oral tablets, single dose

1; 2; 3; 4; 5

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Orlando, Florida, United States

Location

Related Publications (1)

• 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.

  PMID: 26519231 DERIVED

Related Links

• Related Info

MeSH Terms

Conditions

Arthritis, Rheumatoid; Renal Insufficiency

Interventions

fostamatinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Mark Layton, MD

  AstraZeneca

  STUDY DIRECTOR

• Thomas Marbury, MD

  Orlando Clinical

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: November 19, 2010
• First Posted: November 23, 2010
• Study Start: November 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: June 16, 2011

Record last verified: 2011-06

Locations

US (1)