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A Study of Fostamatinib in Subjects With Impaired Kidney Function

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ClinicalTrials.gov Identifier: NCT01245790
Recruitment Status : Completed
First Posted : November 23, 2010
Last Update Posted : June 16, 2011
Sponsor:
Information provided by:
AstraZeneca

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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Renal Impairment Drug: fostamatinib Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : November 2010
Actual Primary Completion Date : June 2011
Actual Study Completion Date : June 2011

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Plasma pharmacokinetic (PK) parameters
    Parameters include: AUC, Cmax


Secondary Outcome Measures :
  1. Safety and tolerability variables of fostamatinib 150mg: Adverse events, vital signs, physical examinations, clinical laboratory tests and electrocardiograms
  2. Urine PK parameters of R406 and its N-glucuronide metabolite
    PK parameters including but not limited to Amount excreted (Ae) and renal clearance (CLr)

  3. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01245790


Locations
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United States, Florida
Research Site
Orlando, Florida, United States
Sponsors and Collaborators
AstraZeneca
Investigators
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Study Director: Mark Layton, MD AstraZeneca
Principal Investigator: Thomas Marbury, MD Orlando Clinical

Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT01245790     History of Changes
Other Study ID Numbers: D4300C00009
First Posted: November 23, 2010    Key Record Dates
Last Update Posted: June 16, 2011
Last Verified: June 2011
Keywords provided by AstraZeneca:
Phase 1
healthy volunteers
volunteers with renal impairment
pharmacokinetics
Rheumatoid arthritis
RA
fostamatinib
Patients
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Renal Insufficiency
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Kidney Diseases
Urologic Diseases