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INS50589 Infusion

Phase 1

Cardiovascular Disease | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jan 21, 2015

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-BlindUNCONTROLLEDBiomarker
Total Trials1
Total Enrollment48
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00099450Study of the Tolerability, Pharmacokinetics, and Pharmacodynamics of INS50589 Intravenous Infusion in Healthy VolunteersPHASE1 COMPLETED 48Dec 1, 2004Mar 1, 2005Jan 21, 20151 United States
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Study Endpoints
Primary Endpoints
Platelet function
Secondary Endpoints
Pilot study - not specified
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSINGLE_GROUP
PurposeTREATMENT
Interventions
NameTypeDescription
INS50589 Intravenous InfusionDRUG -
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Eligibility Criteria
Age Range18 Years — 60 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Have body mass index (BMI) between 18.5 kg/m2 and 35 kg/m2 and body weight no greater than 120 kg. * If female, must not be pregnant or lactating, and if of childbearing potential or sexually active, must use acceptable method of birth control. Exclusion Criteria: * Have cli...

Countries:United States
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