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

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

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01222455

Enrollment

Registered

2010-10-18

Start date

2010-10-31

Completion date

2011-06-30

Last updated

2011-07-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Amount of R406 in Blood, Healthy Volunteers, Hepatic Impairment, Pharmacokinetics

Keywords

Phase 1, Healthy volunteers, Volunteers with hepatic impairment, Pharmacokinetics, Fostamatinib

Brief summary

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.

Interventions

DRUGFostamatinib

Oral tablets, single dose

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

BASIC_SCIENCE

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

Measure	Time frame
To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.	From pre-dose until 120 hours after the single dose

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026