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MK3134

Phase 1

Dementia | Small molecule | Neurology |Merck & Company, Inc.|Last Updated: Nov 2, 2015

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindCONTROLLED
Total Trials2
Total Enrollment57

FDA Designations

No designations recorded

Clinical trial landscape

MK3134 · 2 trials · 1 indication

Phase 1 2
NCT01110616EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)Dementia
COMPLETED25 Analytics
NCT00887601BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)Dementia
COMPLETED32 Analytics
PHASE1COMPLETED
EEG (Electroencephalogram) Platform Standardization in Healthy Male Subjects (3134-010)
DementiaUnlock trial analytics
PHASE1COMPLETED
BOLD Functional Magnetic Resonance Imaging (fMRI) and Cerebral Blood Flow Measurements as Biomarkers for Cognition Enhancing Drugs (3134-006)
DementiaUnlock trial analytics

Study Endpoints

Primary Endpoints

EEG (Electroencephalogram) theta power averaged across a topographical region of interest 6 hours after administration of MK3134/placebo
Baseline and 6 hours
Part I: Difference in number of voxels showing a positive response after treatment with donepezil and placebo
3.5 to 4.5 hours after study drug administration
Part I: Difference in number of voxels activated for both faces and scenes after treatment with donepezil and placebo
3.5 to 4.5 hours after study drug administration
Part II: Number of voxels showing a positive response after varying doses of MK3134 compared to placebo
3.5 to 4.5 hours after study drug administration
Part II: Number of voxels activated for both faces and scenes after varying doses of MK3134 compared to placebo
3.5 to 4.5 hours after study drug administration

Secondary Endpoints

EEG (Electroencephalogram) beta and sigma power averaged across all cortical leads 2 hours after administration of lorazepam/placebo
Baseline and 2 hours
Part I: Difference in arterial transit time as measured by arterial spin labeling after treatment with donepezil and placebo
3.5 to 4.5 hours after study drug administration
Part I: Difference in Pulsatility index after treatment with donepezil and placebo
5 hours after study drug administration
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Sequence 1EXPERIMENTALMK3134-Lorazepam-Placebo-MK3134-Lorazepam
Sequence 2EXPERIMENTALMK3134-Lorazepam-Placebo-Lorazepam-MK3134
Sequence 3EXPERIMENTALMK3134-Placebo-Lorazepam-MK3134-Lorazepam
Sequence 4EXPERIMENTALMK3134-Placebo-Lorazepam-Lorazepam-MK3134
Sequence 5EXPERIMENTALLorazepam-Placebo-MK3134-MK3134-Lorazepam
Sequence 6EXPERIMENTALLorazepam-Placebo-MK3134-Lorazepam-MK3134
Sequence 7EXPERIMENTALLorazepam-MK3134-Placebo-MK3134-Lorazepam
Sequence 8EXPERIMENTALLorazepam-MK3134-Placebo-Lorazepam-MK3134
Sequence 9EXPERIMENTALPlacebo-MK3134-Lorazepam-MK3134-Lorazepam
Sequence 10EXPERIMENTALPlacebo-MK3134-Lorazepam-Lorazepam-MK3134
Sequence 11EXPERIMENTALPlacebo-Lorazepam-MK3134-MK3134-Lorazepam
Sequence 12EXPERIMENTALPlacebo-Lorazepam-MK3134-Lorazepam-MK3134
Part IEXPERIMENTALSubjects will receive placebo, MK3134, and donepezil in one of four treatment sequences.
Part IIEXPERIMENTALSubjects will receive placebo and three different doses of MK3134 (1 mg, 5 mg, and 25 mg) in one of four treatment sequences.

Interventions

NameTypeDescription
MK3134DRUGMK3134, 25 mg tablets (5 x 5 mg capsule), orally
Comparator: LorazepamDRUGLorazepam, 2 mg (2 x 1 mg tablet), orally
Comparator: PlaceboDRUGPlacebo, to match MK3134, and placebo to match Lorazepam
DonepezilDRUGSingle dose 5 mg donepezil capsules in two of the four treatment periods.
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Eligibility Criteria

Age Range18 Years to 40 Years
SexMALE
Healthy VolunteersYes

Inclusion Criteria: * Subject is a male between 18 to 40 years of age * The subject has a Body Mass Index (BMI) greater than or equal to 31 kg/m\^2 at the prestudy (screening) visit * Subject has normal or corrected to normal visual and auditory acuity * Subject has been a nonsmoker and/or has not ...

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Frequently asked questions about MK3134

What is MK3134 used for?

MK3134 is an investigational small molecule being developed by Merck & Company, Inc. for the treatment of dementia. It is currently in Phase 1 clinical development, meaning it is still being studied and has not been approved for use. The drug is being evaluated in early-stage trials to assess its safety and potential effects.

Who makes MK3134?

MK3134 is being developed by Merck & Company, Inc., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol MRK. The drug is currently in Phase 1 clinical trials for dementia, and Merck is conducting research to evaluate its potential as a treatment for this condition.

What phase is MK3134 in?

MK3134 is in Phase 1 clinical development. It is an investigational drug being studied for dementia, and it has not yet been approved by regulatory authorities. The Phase 1 trials are designed to evaluate the drug's safety, tolerability, and early signals of activity in healthy volunteers.

What clinical trials is MK3134 in?

MK3134 has been studied in two completed Phase 1 clinical trials. The first, NCT00887601, involved 32 healthy male participants and used BOLD functional magnetic resonance imaging to assess biomarkers for cognition-enhancing drugs. The second, NCT01110616, enrolled 25 healthy male subjects and focused on standardizing electroencephalogram platforms. Both trials were completed.

Is MK3134 FDA approved?

MK3134 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for dementia. The drug has completed two early-stage trials, but it has not yet demonstrated sufficient evidence of safety and efficacy to receive approval from the U.S. Food and Drug Administration or any other regulatory agency.