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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-06-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Study in Healthy Males to Assess Bioavailability of 4 Different Fostamatinib Tablets

NCT01208155

Bioavailability Pharmacokinetics

COMPLETED PHASE1

Study in Healthy Males to Assess the Bioavailability of 4 Different Fostamatinib Tablets

NCT01387308

Healthy

COMPLETED PHASE1

Assess Pharmacokinetics of Fostamatinib in Fed and Fasted State in Combination With Ranitidine to Assess Bioavailability

NCT01682408

Pharmacokinetics

COMPLETED PHASE1

A Study of MK-1084 in Participants With Hepatic Impairment and Healthy Volunteers (MK-1084-017)

NCT07219550

Healthy Hepatic Impairment

RECRUITING PHASE1

Safety and Pharmacokinetics of Fluzoparib in Healthy Subjects and Those With Impaired Liver Function

NCT04694365

Hepatic Impairment Healthy Subjects

COMPLETED PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Hepatic Impairment Healthy Volunteers Pharmacokinetics Amount of R406 in Blood

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

1

Mild hepatic impairment

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, single dose

2

Moderate hepatic impairment

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, single dose

3

Severe hepatic impairment

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, single dose

4

Matched healthy volunteers with normal hepatic function

Group Type EXPERIMENTAL

Fostamatinib

Intervention Type DRUG

Oral tablets, single dose

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Fostamatinib

Oral tablets, single dose

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes