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MK-6916

Phase 1

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

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
UNCONTROLLED
Total Trials1
Total Enrollment37
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06818968A Study of the Effect of Multiple Doses of Diltiazem on the Plasma Levels of MK-6916 in Healthy Participants (MK-6916-005)PHASE1 COMPLETED 37 — — Feb 27, 2025Aug 8, 2025Aug 26, 20251 United States
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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 — 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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