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FosD

Phase 1

Healthy | Small molecule | Other |AstraZeneca PLC|Last Updated: Feb 7, 2013

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment56

FDA Designations

No designations recorded

Clinical trial landscape

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 an investigational small molecule being developed by AstraZeneca PLC (AZN). It is being studied in a Phase 1 clinical trial to assess its safety, tolerability, and blood and urine drug levels in healthy Japanese and White subjects. FosD is not approved and remains in clinical development.

What is FosD used for?

FosD is being studied for use in healthy volunteers. The Phase 1 trial is designed to evaluate the safety, tolerability, and pharmacokinetics of FosD in healthy Japanese and White subjects. It is not being studied for a specific disease indication at this stage.

Who makes FosD?

FosD is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker AZN. AstraZeneca is conducting a Phase 1 clinical trial to evaluate the safety and tolerability of FosD in healthy subjects.

What phase is FosD in?

FosD is in Phase 1 clinical development. The completed trial, NCT01167868, was a Phase 1 study that assessed the safety, tolerability, and blood and urine drug levels of FosD in healthy Japanese and White subjects. FosD is investigational and not yet approved.

What clinical trials is FosD in?

FosD has one completed clinical 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." This Phase 1 trial enrolled 56 participants in the United States and was placebo-controlled and double-blind.

Is FosD the same as Fostamatinib Disodium?

Yes, FosD is an abbreviation for Fostamatinib Disodium. The clinical trial NCT01167868 refers to the drug as Fostamatinib Disodium (FosD), indicating that FosD is the short name for this compound. The trial evaluated its safety and tolerability in healthy subjects.