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FosD

Phase 1

Undisclosed | Small molecule | Other |AstraZeneca PLC|Trials Updated: Feb 7, 2013

FosD development status

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

FosD clinical trials

FosD · 1 trial · 1 indication

Phase 1 1
NCT01167868A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White SubjectsHealthy
COMPLETED56 Analytics
PHASE1COMPLETED
A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

To investigate safety and tolerability: adverse event monitoring, vital signs, physical examinations, clinical laboratory tests, 12 lead ECG, digital ECG, telemetry.
Prior to treatment, during treatment, and a follow-up visit, a total of up to 20 days

Secondary Endpoints

To determine plasma PK parameters (including but not limited to: AUC, tmax, Cmax, terminal elimination half life (t1/2) and accumulation ratio (Rac)) of FosD.
Plasma sampling for 72 hours following both the single dose and after 7 days repeated dosing.
To determine urine PK parameters (including but not limited to: amount excreted (Ae) and renal clearance (CLr)) of FosD.
Urine sampling for upto 48 hours following both the single dose and after 7 days repeated dosing.
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
FosDEXPERIMENTALFour sequential cohorts of Japanese subjects are planned with doses ranging from 50mg once daily to a maximum of 200mg twice daily. One cohort of White subjects is also planned to receive the same dose regimen as the third dose level in Japanese subjects
PlaceboPLACEBO_COMPARATORPlacebo given (2 subjects in each cohort)

Interventions

NameTypeDescription
FosDDRUGoral tablet
PlaceboDRUGoral tablet
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Eligibility Criteria

Age Range20 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Healthy male and female (of non-childbearing potential) Japanese subjects and White subjects (origins in Europe, the Middle East, or North Africa) * Body mass index (BMI) between 17 and 27 kg/m2 and weigh at least 45 kg and no more than 100 kg Exclusion Criteria: * History o...

Countries:United States
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Frequently asked questions about FosD

What is FosD?

FosD is the short name for fostamatinib disodium, a small molecule drug developed by AstraZeneca PLC. It has been studied in a Phase 1 clinical trial in healthy adult volunteers to assess safety, tolerability, and blood and urine drug levels. FosD is an investigational agent and is not approved for any indication.

Who is developing FosD?

FosD is being developed by AstraZeneca PLC, which trades under the ticker AZN. The company sponsored the Phase 1 trial of fostamatinib disodium in healthy Japanese and White subjects. AstraZeneca is the sole developer named for this asset.

What phase is FosD in?

FosD is in Phase 1 clinical development. One Phase 1 trial has been completed, and no active trials are ongoing. The completed study enrolled 56 healthy volunteers and evaluated safety, tolerability, and drug levels. FosD remains an investigational drug and has not received regulatory approval.

What clinical trials is FosD in?

FosD has been evaluated in one completed Phase 1 trial, NCT01167868, titled "A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White Subjects." The trial enrolled 56 healthy volunteers in the United States and was randomized, double-blind, and placebo-controlled.

Is FosD the same as fostamatinib disodium?

Yes, FosD is an abbreviation for fostamatinib disodium. The two names refer to the same small molecule drug developed by AstraZeneca PLC. The Phase 1 trial NCT01167868 used both terms interchangeably in its title and documentation.