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MK-6916

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Aug 26, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment37

FDA Designations

No designations recorded

Clinical trial landscape

MK-6916 · 1 trial · 1 indication

Phase 1 1
NCT06818968A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)Healthy
COMPLETED37 Analytics
PHASE1COMPLETED
A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)
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Study Endpoints

Primary Endpoints

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of MK-6916
Predose and at designated time points (up to 8 weeks)

Blood samples will be collected to determine the AUC0-inf of MK-6916.

Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-6916
Predose and at designated time points (up to 24 hours)

Blood samples will be collected to determine the AUC0-24 of MK-6916.

Plasma Concentration at 24 Hours (C24) of MK-6916
Predose and at designated time points (up to 24 hours)

Blood samples will be collected to determine the C24 of MK-6916.

Plasma Concentration at 12 Hours (C12) of MK-6916
Predose and at designated time points (up to 12 hours)

Blood samples will be collected to determine the C12 of MK-6916.

Maximum Plasma Concentration (Cmax) of MK-6916
Predose and at designated time points (up to 8 weeks)

Blood samples will be collected to determine the Cmax of MK-6916.

Time to Maximum Plasma Concentration (Tmax) of MK-6916
Predose and at designated time points (up to 8 weeks)

Blood samples will be collected to determine the Tmax of MK-6916.

Apparent Clearance (CL/F) of MK-6916
Predose and at designated time points (up to 8 weeks)

Blood samples will be collected to determine the CL/F of MK-6916.

Apparent Volume of Distribution (Vz/F) of MK-6916
Predose and at designated time points (up to 8 weeks)

Blood samples will be collected to determine the Vz/F of MK-6916.

Apparent Terminal Half-life (t1/2) of MK-6916
Predose and at designated time points (up to 8 weeks)

Blood samples will be collected to determine the t1/2 of MK-6916.

Secondary Endpoints

Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 8 weeks
Number of Participants Who Discontinue Study Treatment Due to an AE
Up to approximately 8 weeks
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
MK-6916 + DiltiazemEXPERIMENTALParticipants will receive MK-6916 and diltiazem orally.

Interventions

NameTypeDescription
MK-6916DRUGOral administration
DiltiazemDRUGOral administration
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: The key inclusion criteria include but are not limited to the following: * Has a body-mass index (BMI) 18 to 32 kg/m\^2 Exclusion Criteria: The key exclusion criteria include but are not limited to the following: * Has a history of clinically significant endocrine, gastroint...

Countries:United States
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Frequently asked questions about MK-6916

What is MK-6916 used for?

MK-6916 is an investigational small molecule being studied in healthy participants. It is currently in Phase 1 clinical development, and the available trial focuses on evaluating its plasma levels when given with multiple doses of diltiazem. MK-6916 is not approved for any condition and remains under investigation.

Who makes MK-6916?

MK-6916 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting clinical trials to evaluate the drug's pharmacokinetics in healthy participants.

What phase is MK-6916 in?

MK-6916 is in Phase 1 clinical development. The single completed trial, NCT06818968, was a Phase 1 study in healthy participants. MK-6916 is investigational and has not been approved by regulatory authorities.

What clinical trials is MK-6916 in?

MK-6916 has one completed Phase 1 trial, NCT06818968, titled "A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)." The study enrolled 37 healthy adults in the United States and was uncontrolled, meaning it did not use a comparator group.

Is MK-6916 FDA approved?

No, MK-6916 is not FDA approved. It is an investigational drug currently in Phase 1 clinical development. The completed trial in healthy participants was designed to assess how diltiazem affects MK-6916 plasma levels, not to establish safety or efficacy for a specific disease.