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MK0752

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Jun 17, 2016

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 Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00803894A Clinical Study to Determine Biomarkers of Response to a Gamma Secretase InhibitorPHASE1 COMPLETED 30Dec 1, 2008Jan 1, 2009Jun 17, 2016 -
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Study Endpoints
Primary Endpoints
To evaluate the existing Notch response signature using plucked hair follicle profiling data from health young male volunteers given 1000 mg MK0752 and 350 mg MK0752.
8.5 hours post dose.
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
AACTIVE_COMPARATORMK0752 1000 mg
BACTIVE_COMPARATORMK0752 350 mg
CPLACEBO_COMPARATORPlacebo
Interventions
NameTypeDescription
MK0752DRUGSingle dose MK0752 capsules, 1000 mg: there will be a 7-day washout period between treatments.
Comparator: MK0752.DRUGSingle dose MK0752 capsules, 350 mg: there will be a 7-day washout period between treatments.
Comparator: PlaceboDRUGSingle dose placebo capsules: there will be a 7-day washout period between treatments.
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Eligibility Criteria
Age Range18 Years — 35 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Patient is a male * Patient has no clinically significant abnormality on electrocardiogram performed * Patient agrees to not to consume apple juice, grapefruit or grapefruit products beginning 2 weeks prior to first dose of study drug and for the duration of the study * Patien...

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