A Study of Fostamatinib in Subjects With Impaired Kidney Function

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01245790
First received: November 19, 2010
Last updated: June 15, 2011
Last verified: June 2011
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
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
Autoimmune Diseases
Connective Tissue Diseases
Immune System Diseases
Joint Diseases
Kidney Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Urologic Diseases

ClinicalTrials.gov processed this record on October 23, 2014