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Completed

NCT Number: NCT01222455

A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function

A study to evaluate the amount of fostamatinib in the blood in subjects with impaired hepatic (liver) function compared with healthy volunteers with normal liver function. The study will also evaluate safety and tolerability in subjects with hepatic impairment.

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Key information

Conditions

Hepatic Impairment Amount of R406 in Blood Healthy Volunteers Pharmacokinetics

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Orlando, Florida, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Males and females (non child-bearing potential) aged 18 years or more, with a weight of at least 50 kg and body mass index (BMI) between 18 and 40 kg/m2 inclusive
  • Healthy subjects only: good health as determined by a medical history, physical examination , ECG and clinical laboratory evaluations
  • Healthy subjects only: negative results for serum hepatitis B and C

Exclusion criteria

  • Subjects who have received any medications known to alter drug absorption or elimination within 30 days of first dose.
  • Subjects who smoke more than 10 cigarettes or equivalent per day
  • Absolute neutrophil count <2500/mm3
  • Abnormal vital signs, additional systemic disease (eg, cardiac, or renal disease) or abnormal laboratory findings that are judged to be clinically significant by the investigator
  • Healthy volunteers only: use of prescribed medications within 2 weeks of first dose or use of non-prescribed medications within 1 week of first dose
  • Hepatic subjects only: fluctuating or rapidly deteriorating hepatic function

Treatment and study plan

Fostamatinib

Drug

Oral tablets, single dose

Primary outcomes

  1. To determine plasma PK parameters of R406 in subjects with varying degrees of hepatic impairment as well as in healthy subjects (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2))

    Time frame: From pre-dose until 120 hours after the single dose

Secondary outcomes

  1. To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.

    Time frame: From pre-dose until 120 hours after the single dose

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

An Open-label, Single-center Study to Assess the Pharmacokinetics of R406 in Subjects With Hepatic Impairment and in Healthy Subjects Following Administration of a Single Dose of Fostamatinib Disodium 150 mg

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Oct 18, 2010
Registry last updated
Jul 6, 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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