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

Healthy Volunteers Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222455
• Other study ID #: D4300C00010
• Status: Completed
• Phase: Phase 1
• First received: October 15, 2010
• Last updated: July 5, 2011
• Start date: October 2010
• Est. completion date: June 2011

Study information

• Verified date: July 2011
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: June 2011
• Est. primary completion date: June 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Amount of R406 in Blood
• Healthy Volunteers
• Hepatic Impairment
• Liver Diseases
• Pharmacokinetics

Intervention

Drug:
• Fostamatinib
Oral tablets, single dose

Locations

Country	Name	City	State
United States	Research Site	Orlando	Florida

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	Yes