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MK-1403 formulation 1+ additive

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Aug 19, 2026

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment15

FDA Designations

No designations recorded

Clinical trial landscape

MK-1403 formulation 1+ additive · 1 trial · 1 indication

Phase 1 1
NCT07677163A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)Healthy
RECRUITING15 Analytics
PHASE1RECRUITING
A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 4 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Number of Participants Who Discontinue the Study Intervention Due to an AE
Up to approximately 2 weeks

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf) of MK-1403
Predose and at designated timepoints (up to 72 hours postdose)

Blood samples will be collected to determine the AUC0-inf of MK-1403 in plasma.

Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-last) of MK-1403
Predose and at designated timepoints (up to 72 hours postdose)

Blood samples will be collected to determine the AUC0-last of MK-1403 in plasma.

Maximum Plasma Concentration (Cmax) of MK-1403
Predose and at designated timepoints (up to 72 hours postdose)

Blood samples will be collected to determine the Cmax of MK-1403 in plasma.

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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelCROSSOVER
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
MK-1403 formulation (FM) 1 + additive, FedEXPERIMENTALMK-1403 FM 1 + additive tablet administered once orally at study dose after a high-fat meal.
MK-1403 FM1 + additive, FastedEXPERIMENTALMK-1403 FM1 + additive tablet administered once orally at study dose in a fasted state.
MK-1403 FM2 + additive, FedEXPERIMENTALMK-1403 FM2 tablet + additive administered once orally at study dose after a high-fat meal.

Interventions

NameTypeDescription
MK-1403 formulation (FM) 1 + additiveDRUGOral tablet
MK-1403 FM2 + additiveDRUGOral tablet
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is in good health * Has a body mass index (BMI) ≥ 18 and ≤ 32 kg/m\^2 Exclusion Criteria: * Has history of cancer (malignancy) * Has a history of significant multiple and/or severe allergies

Countries:United States
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Recent Changes (Last 90 Days)

LOWAug 20, 2026NCT07677163Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07677163Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07677163Status: NOT_YET_RECRUITING → RECRUITING
LOWAug 20, 2026NCT07677163Status: NOT_YET_RECRUITING → RECRUITING
LOWJun 30, 2026NCT07677163NEW_TRIAL: changed
LOWJun 30, 2026NCT07677163NEW_TRIAL: changed
LOWJun 30, 2026NCT07677163NEW_TRIAL: changed

Frequently asked questions about MK-1403 formulation 1+ additive

What is MK-1403 formulation 1+ additive?

MK-1403 formulation 1+ additive is an investigational small molecule being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development for use in healthy participants. The drug is also known as MK-1403 formulation (FM) 1 + additive.

What is MK-1403 formulation 1+ additive used for?

MK-1403 formulation 1+ additive is being studied in healthy participants as part of early clinical development. The ongoing Phase 1 trial is designed to evaluate the drug in healthy volunteers, with no specific disease condition being targeted at this stage.

Who makes MK-1403 formulation 1+ additive?

MK-1403 formulation 1+ additive is being developed by Merck & Company, Inc., a pharmaceutical company traded on the stock exchange under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial of this investigational small molecule.

What phase is MK-1403 formulation 1+ additive in?

MK-1403 formulation 1+ additive is in Phase 1 clinical development. It is an investigational drug that has not yet been approved by regulatory authorities. The ongoing Phase 1 trial is currently recruiting participants in the United States.

What clinical trials is MK-1403 formulation 1+ additive in?

MK-1403 formulation 1+ additive is being evaluated in a single Phase 1 clinical trial with the identifier NCT07677163, titled "A Clinical Trial of MK-1403 in Healthy Participants (MK-1403-007)." The trial is recruiting 15 healthy participants aged 18 years and older in the United States.

Is MK-1403 formulation 1+ additive the same as MK-1403 formulation (FM) 1 + additive?

Yes, MK-1403 formulation 1+ additive is the same as MK-1403 formulation (FM) 1 + additive. These names refer to the same investigational drug being developed by Merck & Company, Inc. for use in healthy participants.