Clinical trial NCT01222455: A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Hepatic Impairment
Healthy Volunteers
Pharmacokinetics
Amount of R406 in Blood
Keywords: Phase 1
Healthy volunteers
Volunteers with hepatic impairment
Pharmacokinetics
Fostamatinib
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2010-10-18
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: 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))
timeFrame: From pre-dose until 120 hours after the single dose
Secondary outcomes:
measure: To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
timeFrame: From pre-dose until 120 hours after the single dose
Other outcomes:
Locations:
city: Orlando
country: United States
facility: Research Site
state: Florida
Study officials:
affiliation: Orlando Clinical Research Center
name: Thomas Marbury, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Martin P, Oliver S, Gillen M, Marbury T, Millson D. Pharmacokinetic Properties of Fostamatinib in Patients With Renal or Hepatic Impairment: Results From 2 Phase I Clinical Studies. Clin Ther. 2015 Dec 1;37(12):2823-36. doi: 10.1016/j.clinthera.2015.09.016. Epub 2015 Oct 27.