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FOSTAMATIN

Phase 1

Drug Drug Interactions | Small molecule | Other |AstraZeneca PLC|Last Updated: Nov 23, 2010

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
CONTROLLED
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT01197781Evaluation of the Drug-drug Interaction Between FosD and Verapamil When Taken Together in Healthy VolunteersPHASE1 COMPLETED 15 — — Sep 1, 2010Oct 1, 2010Nov 23, 20101 United States
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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 — 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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