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NSA-789

Phase 1

Healthy | Small molecule | Other |Pfizer, Inc.|Last Updated: Feb 17, 2009

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_CONTROLLED
Total Trials2
Total Enrollment120
FDA Designations
No designations recorded
Clinical Trials (2)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00619736Study Evaluating the Safety, Tolerability and Pharmacokinetics of NSA-789 in Healthy Japanese Male SubjectsPHASE1 COMPLETED 56Mar 1, 2008Sep 1, 2008Jan 30, 2009 -
NCT00633048Study Evaluating the Safety and Tolerability of NSA-789PHASE1 COMPLETED 64Mar 1, 2008May 1, 2008Feb 17, 20091 United States
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Study Endpoints
Primary Endpoints
Safety and Tolerability
3 months
Safety and tolerability from reported adverse events, scheduled physical examinations, vital signs, cardiac rhythm monitoring, 12-lead ECGs, and clinical laboratory test results
3 months
Secondary Endpoints
Pharmacokinetics
3 months
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
Treatment Arms
ArmTypeDescription
NSA-789EXPERIMENTAL -
PlaceboPLACEBO_COMPARATOR -
Interventions
NameTypeDescription
NSA-789DRUG -
PlaceboOTHER -
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Eligibility Criteria
Age Range20 Years — 45 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Men aged 20 to 45 years inclusive at screening. * Healthy as determined by the investigator on the basis of screening evaluations. Exclusion Criteria: * Any significant cardiovascular, hepatic, renal, respiratory, gastrointestinal, endocrine, immunologic, dermatologic, hemat...

Countries:United States
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