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

Primary Purpose

Hepatic Impairment, Healthy Volunteers, Pharmacokinetics

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Fostamatinib
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Hepatic Impairment focused on measuring Phase 1, Healthy volunteers, Volunteers with hepatic impairment, Pharmacokinetics, Fostamatinib

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Research Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

1

2

3

4

Arm Description

Mild hepatic impairment

Moderate hepatic impairment

Severe hepatic impairment

Matched healthy volunteers with normal hepatic function

Outcomes

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))

Secondary Outcome Measures

To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.

Full Information

First Posted
October 15, 2010
Last Updated
July 5, 2011
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01222455
Brief Title
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
October 2010 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
AstraZeneca

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatic Impairment, Healthy Volunteers, Pharmacokinetics, Amount of R406 in Blood
Keywords
Phase 1, Healthy volunteers, Volunteers with hepatic impairment, Pharmacokinetics, Fostamatinib

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
32 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Mild hepatic impairment
Arm Title
2
Arm Type
Experimental
Arm Description
Moderate hepatic impairment
Arm Title
3
Arm Type
Experimental
Arm Description
Severe hepatic impairment
Arm Title
4
Arm Type
Experimental
Arm Description
Matched healthy volunteers with normal hepatic function
Intervention Type
Drug
Intervention Name(s)
Fostamatinib
Intervention Description
Oral tablets, single dose
Primary Outcome Measure Information:
Title
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))
Time Frame
From pre-dose until 120 hours after the single dose
Secondary Outcome Measure Information:
Title
To investigate safety and tolerability of fostamatinib 150mg: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Time Frame
From pre-dose until 120 hours after the single dose

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Marbury, MD
Organizational Affiliation
Orlando Clinical Research Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Research Site
City
Orlando
State/Province
Florida
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
26519231
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.
Results Reference
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A Study of Fostamatinib in Subjects With Impaired Hepatic (Liver) Function

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