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MK0974 Ethanolate formulation

Phase 1

Migraine | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Jul 7, 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
RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00965887Bioequivalence of Two Tablet Forms of MK0974 (0974-045)PHASE1 COMPLETED 36Mar 1, 2008May 1, 2008Jul 7, 2015 -
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Study Endpoints
Primary Endpoints
Area under the curve (AUC(0 to infinity) following single dose administration of MK0974 ethanolate or hydrate formulations
Through 48 hours postdose
Peak plasma concentration (Cmax) following single dose administration of MK0974 ethanolate or hydrate formulations
Through 48 Hours Post Dose
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Study Design & Arms
AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
1ACTIVE_COMPARATORMK0974 Ethanolate
2ACTIVE_COMPARATORMK0974 Hydrate
Interventions
NameTypeDescription
MK0974 Ethanolate formulationDRUGSingle dose MK0974 280 mg tablet in one of two treatment periods
Comparator: MK0974 Hydrate formulationDRUGSingle dose MK0974 280 mg tablet in one of two treatment periods
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes

Inclusion Criteria: * Subject is in good health * Subject is a non-smoker * Subject is willing to comply with the study restrictions Exclusion Criteria: * Subject has a history of stroke, chronic seizures, or major neurological disorder * Subject has a history of cancer * Subject is a nursing mot...

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