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FOSTAMATIN

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Nov 23, 2010

FOSTAMATIN development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Sep 2010

FOSTAMATIN target and mechanism

Molecular targetSYK
Target classInhibitor
ModalitySmall molecule

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

FOSTAMATIN clinical trials

FOSTAMATIN · 1 trial · 2 indications

Phase 1 1
NCT01197781Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy VolunteersDrug Drug Interactions
COMPLETED15 Analytics
PHASE1COMPLETED
Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers
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Study Endpoints

Primary Endpoints

To determine plasma PK parameters of R406 when FosD is given in combination with verapamil (including but not limited to: AUC, tmax, Cmax and terminal elimination half life (t1/2)) of FosD.
Daily during Treatment Period 1 (FosD alone) and Treatment Period 2 (FosD plus verapamil) until 96 hours post each single dose of FosD

Secondary Endpoints

To investigate safety and tolerability of FosD when given in combination with verapamil: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, ECGs.
Screening, throughout both treatment periods, and follow-up.
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
Period 1EXPERIMENTAL -
Period 2EXPERIMENTAL -

Interventions

NameTypeDescription
FOSTAMATINDRUGOral tablets - single dose
VerapamilDRUGOral tablets - administered 3 times daily over 4 days
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Weight of at least 50 kg (110 lbs) and body mass index (BMI) between 18 and 35 kg/m2, inclusive. * Females must be of non-childbearing potential Exclusion Criteria: * History of clinically significant disease or disorder or presence of GI, hepatic or renal disease * Any clin...

Countries:United States
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Frequently asked questions about FOSTAMATIN

What is fostamatinib?

Fostamatinib is a small molecule drug developed by AstraZeneca PLC (ticker AZN). It is a SYK inhibitor that has been studied in Phase 1 clinical development. Its therapeutic indications have not been disclosed.

What does fostamatinib target?

Fostamatinib targets SYK, spleen tyrosine kinase. It acts as an inhibitor of this enzyme. SYK is a signaling molecule involved in immune cell activation, which is why SYK inhibitors are studied across a range of conditions.

Who makes fostamatinib?

Fostamatinib is developed by AstraZeneca PLC, which trades under the ticker AZN. AstraZeneca is the sponsor associated with the clinical development of this SYK inhibitor small molecule.

What phase is fostamatinib in?

Fostamatinib is in Phase 1 clinical development. It is an investigational small molecule and has not been approved by the FDA. The Phase 1 program includes one completed trial, and no trials are currently active.

What clinical trials is fostamatinib in?

Fostamatinib has been evaluated in one completed Phase 1 trial, NCT01197781, titled Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy Volunteers. That trial enrolled 15 healthy adult volunteers in the United States and used a controlled design.

Is fostamatinib the same as FosD?

Yes, FosD is another name used for fostamatinib. The completed Phase 1 drug-drug interaction trial, NCT01197781, refers to the drug as FosD in its title, evaluating the interaction between FosD and verapamil when taken together in healthy volunteers.