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

Sponsor

AstraZeneca (Industry)

Overall Status

Completed

CT.gov ID

NCT01222455

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hepatic Impairment Healthy Volunteers Pharmacokinetics Amount of R406 in Blood	Drug: Fostamatinib	Phase 1

Study Design

Study Type:

Interventional

Anticipated Enrollment :

32 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official 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

Study Start Date :

Oct 1, 2010

Actual Primary Completion Date :

Jun 1, 2011

Actual Study Completion Date :

Jun 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 1 Mild hepatic impairment	Drug: Fostamatinib Oral tablets, single dose
Experimental: 2 Moderate hepatic impairment	Drug: Fostamatinib Oral tablets, single dose
Experimental: 3 Severe hepatic impairment	Drug: Fostamatinib Oral tablets, single dose
Experimental: 4 Matched healthy volunteers with normal hepatic function	Drug: Fostamatinib Oral tablets, single dose

Outcome Measures

Primary Outcome Measures

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

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts 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