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MK0974 Ethanolate formulation

Phase 1

Migraine | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Jul 7, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedACTIVE_CONTROLLED
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

MK0974 Ethanolate formulation · 1 trial · 1 indication

Phase 1 1
NCT00965887Bioequivalence of Two Tablet Forms of MK0974 (0974-045)Migraine
COMPLETED36 Analytics
PHASE1COMPLETED
Bioequivalence of Two Tablet Forms of MK0974 (0974-045)
MigraineUnlock trial analytics

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 to 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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Competitive Landscape -Migraine 30 trials

Frequently asked questions about MK0974 Ethanolate formulation

What is MK0974 Ethanolate formulation used for?

MK0974 Ethanolate formulation is an investigational small molecule being developed for the treatment of migraine. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes MK0974 Ethanolate formulation?

MK0974 Ethanolate formulation is being developed by Merck & Company, Inc. (NYSE: MRK). The company is conducting clinical trials to evaluate this investigational migraine treatment.

What phase is MK0974 Ethanolate formulation in?

MK0974 Ethanolate formulation is in Phase 1 clinical development. It is an investigational drug and has not been approved for any use. One Phase 1 trial has been completed.

What clinical trials is MK0974 Ethanolate formulation in?

MK0974 Ethanolate formulation has one completed clinical trial, NCT00965887, titled "Bioequivalence of Two Tablet Forms of MK0974 (0974-045)." This Phase 1 study enrolled 36 participants and evaluated the drug in healthy volunteers.

Is MK0974 Ethanolate formulation the same as MK0974?

MK0974 Ethanolate formulation is a specific formulation of MK0974, the active drug substance. The clinical trial NCT00965887 compares two tablet forms of MK0974, including the ethanolate formulation, to assess their bioequivalence.