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MK-4318

Phase 1

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

MK-4318 development status

Highest phase Phase 1
Registered trials 1 across 1 sponsor since Nov 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment19

FDA Designations

No designations recorded

MK-4318 clinical trials

MK-4318 · 1 trial · 2 indications

Phase 1 1
NCT06692647A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)Healthy
COMPLETED19 Analytics
PHASE1COMPLETED
A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003)
HealthyUnlock trial analytics

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 to 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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Frequently asked questions about MK-4318

What is MK-4318?

MK-4318 is an investigational small molecule being developed by Merck & Company, Inc. (ticker MRK) for pain. It is in Phase 1 clinical development and has been studied in healthy volunteers. It is not an approved medicine.

What is MK-4318 used for?

MK-4318 is being developed for the treatment of pain. Its clinical testing so far has involved healthy adult volunteers rather than patients with a pain condition, so its use in pain is still under investigation and it is not approved for any indication.

Who makes MK-4318?

MK-4318 is developed by Merck & Company, Inc., which trades under the ticker MRK. Merck is the sponsor of the clinical program studying the compound.

What phase is MK-4318 in?

MK-4318 is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. The compound remains investigational and has not been approved by the FDA for any use.

What clinical trials is MK-4318 in?

MK-4318 has been studied in one Phase 1 trial, NCT06692647, titled A Clinical Study of MK-4318 and Diltiazem in Healthy People (MK-4318-003). The trial enrolled 19 participants in the United States, included healthy volunteers, and is now completed.

How was the MK-4318 Phase 1 trial designed?

The completed Phase 1 trial NCT06692647 enrolled 19 healthy adult volunteers of all sexes, aged 18 years and older, in the United States. It was an uncontrolled study without randomization or double blinding, and it evaluated MK-4318 together with diltiazem.