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FosD

Phase 1

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

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment56
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01167868A Study to Assess the Safety, Tolerability, and Blood and Urine Drug Levels of Fostamatinib Disodium (FosD) in Healthy Japanese and White SubjectsPHASE1 COMPLETED 56 — — Jul 1, 2010May 1, 2011Feb 7, 20131 United States
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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 — 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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