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INCB13739

Phase 1

Insulin Resistance | Small molecule | Metabolic |Incyte Corporation|Last Updated: Jan 23, 2012

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-BlindUNCONTROLLED
Total Trials1
Total Enrollment -
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00398619A Study of the Effect of INCB013739 on Cortisone Reducing Enzyme Activity in Obese People Predisposed to DiabetesPHASE1 COMPLETED -Nov 1, 2006Mar 1, 2007Jan 23, 20122 United States
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Study Endpoints
Primary Endpoints
Assessment of pharmacokinetics of INCB013739 through analysis of blood samples.
Serial collections at each visit
Evaluation of change in cortisol laboratory values
Serial collections at each visit
Assessment of ECGs, laboratory results and physical exams for adverse events
Measured from baseline through study completion
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT
Interventions
NameTypeDescription
INCB13739DRUG -
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites2

Inclusion Criteria: * Male and female subjects between 18 years and 65 years of age. * BMI between 30 and 42 kg/m2, inclusive. * FPG \<126 mg/dL Exclusion Criteria: * Meet criteria for diagnosis of diabetes mellitus at the screening evaluation, female subjects with a history of gestational diabet...

Countries:United States
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