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

Phase 1

Completed

• Conditions: Hepatic Impairment; Healthy Volunteers; Pharmacokinetics; Amount of R406 in Blood
• Interventions: Drug: Fostamatinib

• Registration Number: NCT01222455
• Lead Sponsor: AstraZeneca

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-10
• Study First Submitted: 2010-10-15
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Primary Completion: 2011-06
• Study Completion: 2011-06
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-05
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3	Fostamatinib	Severe hepatic impairment
2	Fostamatinib	Moderate hepatic impairment
1	Fostamatinib	Mild hepatic impairment
4	Fostamatinib	Matched healthy volunteers with normal hepatic function

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Research Site; 🇺🇸 Orlando, Florida, United States