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MK-4318

Phase 1

Healthy | Small molecule | Pain |Merck & Company, Inc.|Last Updated: Nov 18, 2024

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 Enrollment19
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06692647A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)PHASE1 COMPLETED 19 — — Feb 9, 2024Apr 11, 2024Nov 18, 20241 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-4318
At designated timepoints (up to approximately 4 days postdose)

Blood samples will be collected to determine the AUC0-inf of MK-4318 in the presence of diltiazem.

Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of MK-4318
At designated timepoints (up to approximately 1 day postdose)

Blood samples will be collected to determine the AUC0-24hrs of MK-4318 in the presence of diltiazem.

Plasma Concentration of MK-4318 at 12 Hours Postdose (C12hrs)
At designated timepoints (up to approximately 12 hours postdose)

Blood samples will be collected to determine the C12hrs of MK-4318 in the presence of diltiazem.

Plasma Concentration of MK-4318 at 24 Hours Postdose (C24hrs)
At designated timepoints (up to approximately 1 day postdose)

Blood samples will be collected to determine the C24hrs of MK-4318 in the presence of diltiazem.

Maximum Plasma Concentration (Cmax) of MK-4318
At designated timepoints (up to approximately 4 days postdose)

Blood samples will be collected to determine the Cmax of MK-4318 in the presence of diltiazem.

Time to Maximum Plasma Concentration (Tmax) of MK-4318
At designated timepoints (up to approximately 4 days postdose)

Blood samples will be collected to determine the Tmax of MK-4318 in the presence of diltiazem.

Apparent Clearance (CL/F) of MK-4318
At designated timepoints (up to approximately 4 days postdose)

Blood samples will be collected to determine the CL/F of MK-4318 in the presence of diltiazem.

Apparent Volume of Distribution During Terminal Phase (Vz/F) of MK-4318
At designated timepoints (up to approximately 4 days postdose)

Blood samples will be collected to determine the Vz/F of MK-4318 in the presence of diltiazem.

Apparent Terminal Half-life (t1/2) of MK-4318
At designated timepoints (up to approximately 4 days postdose)

Blood samples will be collected to determine the t1/2 of MK-4318 in the presence of diltiazem.

Secondary Endpoints
Number of Participants Who Experience an Adverse Event (AE)
Up to approximately 60 days
Number of Participants Who Discontinue Study Intervention Due to an AE
Up to approximately 9 days
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
MK-4318 Plus DiltiazemEXPERIMENTALParticipants will move sequentially through 2 Periods. In Period 1, participants receive MK-4318 orally. In Period 2, participants receive MK-4318 orally plus diltiazem orally.
Interventions
NameTypeDescription
MK-4318DRUGOral administration
DiltiazemDRUGOral administration
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Eligibility Criteria
Age Range18 Years — 55 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria The main inclusion criteria include but are not limited to the following: * Is in good health based on medical history and physical examination * Has a body mass index \>18 and ≤32 kg/m\^2, inclusive Exclusion Criteria The main exclusion criteria include but are not limited to...

Countries:United States
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