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

NCT01222455 | Completed Phase 1

• 1 other identifier: D4300C00010
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (4)

1

EXPERIMENTAL

Mild hepatic impairment

Drug: Fostamatinib

2

EXPERIMENTAL

Moderate hepatic impairment

Drug: Fostamatinib

3

EXPERIMENTAL

Severe hepatic impairment

Drug: Fostamatinib

4

EXPERIMENTAL

Matched healthy volunteers with normal hepatic function

Drug: Fostamatinib

Interventions

Fostamatinib DRUG

Oral tablets, single dose

1; 2; 3; 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• AstraZeneca: lead

Study Sites (1)

Research Site

Orlando, Florida, United States

Location

Related Publications (1)

• 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.

  PMID: 26519231 DERIVED

MeSH Terms

Interventions

fostamatinib

Study Officials

• Thomas Marbury, MD

  Orlando Clinical Research Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: October 15, 2010
• First Posted: October 18, 2010
• Study Start: October 1, 2010
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

US (1)