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MK2637

Phase 1

Schizophrenia | Small molecule | Psychiatry |Merck & Company, Inc.|Last Updated: Jun 24, 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-BlindPLACEBO_CONTROLLEDBiomarker
Total Trials1
Total Enrollment15
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT00934466Study of the Effect of Single Doses of MK2637 and Dextromethorphan on Cerebral Cortex Excitability (2637-008)PHASE1 COMPLETED 15Jul 1, 2009Dec 1, 2009Jun 24, 2015 -
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Study Endpoints
Primary Endpoints
Increase in Motor Evoked Potential (MEP) after dosing with dextromethorphan compared to placebo
5 Hours after initial dosing
Increase in amplitude in the gamma frequency band (24-60 Hz) of resting qEEG after dosing with dextromethorphan compared to placebo
4 Hours after initial dosing
Secondary Endpoints
Increase in amplitude in the theta frequency band (4-8 Hz) of resting qEEG after dosing with MK2637 compared to placebo
6.5 hours after initial dosing
Change in Motor Evoked Potential (MEP) after dosing with MK2637 as compared to placebo
5 hours after initial dosing
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeDIAGNOSTIC
Treatment Arms
ArmTypeDescription
1EXPERIMENTALMK2637 120 mg
2EXPERIMENTALMK2637 50 mg
3PLACEBO_COMPARATORPlacebo
4ACTIVE_COMPARATORDextromethorphan 220 mg
5ACTIVE_COMPARATORDextromethorphan 110 mg
Interventions
NameTypeDescription
MK2637DRUGSingle dose of 120 mg MK2637 capsules in one of five treatment periods.
Comparator: MK2637DRUGSingle dose of 50 mg MK2637 capsules in one of five treatment periods.
Comparator: PlaceboDRUGSingle dose of placebo only in one of five treatment periods.
Comparator: DextromethorphanDRUGSingle dose of 220 mg dextromethorphan capsules in one of five treatment periods.
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Eligibility Criteria
Age Range18 Years — 40 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is right-handed * Subject is in good health * Subject is a nonsmoker Exclusion Criteria: * Subject works a night shift * Subject has a history of any illness that might make participation in the study unsafe or confound the study results * Subject has a history of he...

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