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TAK-233

Phase 1

Clinical Pharmacology | Small molecule | Other |Takeda Pharmaceutical Company Limited|Last Updated: Oct 21, 2014

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 Enrollment24
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT02113020A Phase I Clinical Pharmacology Study of TAK-233 in Healthy SubjectsPHASE1 COMPLETED 24Feb 1, 2014Sep 1, 2014Oct 21, 20141 Japan
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Study Endpoints
Primary Endpoints
Change from baseline in motor threshold for urethral sphincter contraction.
0.5 hours post-dose
Secondary Endpoints
Number of participants with adverse events
Up to 28 days
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelCROSSOVER
PurposeBASIC_SCIENCE
Treatment Arms
ArmTypeDescription
TAK-233EXPERIMENTALOral administration
PlaceboPLACEBO_COMPARATOROral administration
Interventions
NameTypeDescription
TAK-233DRUGOral administration of TAK-233
PlaceboDRUGOral admininstration of Placebo
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Eligibility Criteria
Age Range20 Years — 40 Years
SexFEMALE
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Subjects who understand the contents of this clinical trial and who the investigator or sub-investigator consider able to comply with the procedures of the clinical trial 2. Subjects who can sign the informed consent form and can date the form without assistance before starti...

Countries:Japan
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