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MK-5475

Phase 1

Healthy | Small molecule | Other |Merck & Company, Inc.|Last Updated: Oct 29, 2025

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment8

FDA Designations

No designations recorded

Clinical trial landscape

MK-5475 · 1 trial · 1 indication

Phase 1 1
NCT06777602A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)Healthy
COMPLETED8 Analytics
PHASE1COMPLETED
A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)
HealthyUnlock trial analytics

Study Endpoints

Primary Endpoints

Amount Excreted in Urine (Aeu)
At designated time points (Up to ~ 23 days)

Amount of \[14C\]MK-5475 and its metabolites excreted in urine (Aeu) derived from urine collections at each sampling interval.

Cumulative Aeu
At designated time points (Up to ~ 23 days)

Cumulative amount of \[14C\] MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval

Percentage Excreted in Urine (feu)
At designated time points (Up to ~ 23 days)

Percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.

Cumulative feu
At designated time points (Up to ~ 23 days)

Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in urine derived from urine collections at each sampling interval.

Amount Excreted in Feces (Aef)
At designated time points (Up to ~ 23 days)

Amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.

Cumulative Aef
At designated time points (Up to ~ 23 days)

Cumulative amount of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.

Cumulative Fef
At designated time points (Up to ~ 23 days)

Cumulative percentage of \[14C\]MK-5475 and its metabolites excreted in feces derived from feces collections at each sampling interval.

AUC0-t
At designated time points (Up to ~ 23 days)

Area under concentration time curve (AUC) from time zero to the last quantifiable concentration derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475.

AUC0-infinity
At designated time points (Up to ~ 23 days)

AUC from time zero extrapolated to infinity derived from the whole blood and plasma concentration-time profiles following IV administration of \[14C\]MK-5475.

Maximum Plasma Concentration (Cmax)
At designated time points (Up to ~ 23 days)

Cmax is the measure of the maximum amount of \[14C\]MK-5475 in the plasma after the dose is given.

Half-life t1/2
At designated time points (Up to ~ 23 days)

T1/2 is the time required for \[14C\]MK-5475 concentration in the plasma to decrease by 50%.

Time to Maximum Plasma Concentration (Tmax),
At designated time points (Up to ~ 23 days)

Tmax is a measure of the time to reach the maximum concentration in the plasma after the \[14C\]MK-5475 dose.

Apparent Total Clearance (CL; MK-5475 only)
At designated time points (Up to ~ 23 days)

CL is defined as apparent total clearance of \[14C\]MK-5475 from plasma after IV administration

Apparent Volume of Distribution (Vz; MK-5475 only)
At designated time points (Up to ~ 23 days)

Vz is defined as apparent volume of distribution of \[14C\]MK-5475 during terminal phase after IV administration.

AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio
At designated time points (Up to ~ 23 days)

AUC time zero to infinity (0-∞) of \[14C\]MK-5475 in plasma/AUC0-∞ of total radioactivity in plasma.

Secondary Endpoints

Number of Participants Who Experience an Adverse Event (AE)
Up to ~ 30 days
Number of Participants Who Discontinue Study Due to an AE
Up to ~ 30 days
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeBASIC_SCIENCE

Treatment Arms

ArmTypeDescription
[14C] MK-5475EXPERIMENTAL\[14C\] MK-5475 is administered as single IV bolus dose of 100μg on Day 1.

Interventions

NameTypeDescription
[14C] MK-5475DRUG\[14C\] MK-5475 is administered as a single IV bolus dose in healthy male participants on Day 1.
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Eligibility Criteria

Age Range18 Years to 50 Years
SexMALE
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * Is in good health. * Body mass index (BMI) \>18 and ≤32 kg/m2, inclusive. Exclusion Criteria: * Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological ...

Countries:United States
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Frequently asked questions about MK-5475

What is MK-5475?

MK-5475 is an investigational small molecule being developed by Merck & Company, Inc. (MRK). It is currently in Phase 1 clinical development. The drug is being studied in healthy participants to understand how it is taken up by the body, broken down, and removed.

What is MK-5475 used for?

MK-5475 is being studied in healthy participants as part of a Phase 1 clinical trial. The study is designed to understand how the radiolabeled form of the drug is absorbed, metabolized, and excreted from the body. It is not yet approved for any medical condition.

Who makes MK-5475?

MK-5475 is being developed by Merck & Company, Inc., which trades under the ticker symbol MRK. The company is conducting a Phase 1 clinical trial to evaluate the drug's absorption, metabolism, and elimination in healthy male participants.

What phase is MK-5475 in?

MK-5475 is in Phase 1 clinical development. The single completed trial, NCT06777602, enrolled 8 healthy male participants in the United States. The drug is investigational and has not been approved by regulatory authorities.

What clinical trials is MK-5475 in?

MK-5475 has one completed Phase 1 clinical trial, NCT06777602, titled "A Clinical Study To Understand How Radiolabeled MK-5475 Is Taken Up By The Body, Broken Down And Then Removed From The Body in Healthy Participants (MK-5475-011)." The trial enrolled 8 healthy male participants aged 18 years and older in the United States.