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OpenTrials
Completed

NCT Number: NCT01245790

A Study of Fostamatinib in Subjects With Impaired Kidney Function

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.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Fostamatinib

Drug

Oral tablets, single dose

Primary outcomes

  1. Plasma pharmacokinetic (PK) parameters

    Parameters include: AUC, Cmax

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2010
Registry last updated
Jun 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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