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)

NCT06777602 | Completed Phase 1 FDA Drug

• 2 other identifiers: 5475-011MK-5475-011
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to understand how radiolabeled MK-5475 administered intravenously (IV) is taken up by the body, broken down and then removed from the body in healthy male participants. The study also aims to understand how much of the compound is broken down and how much leaves the body unchanged.

Conditions

Healthy

Outcome Measures

Primary Outcomes (15)

• Amount Excreted in Urine (Aeu)

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

  At designated time points (Up to ~ 23 days)

• Cumulative Aeu

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

  At designated time points (Up to ~ 23 days)

• Percentage Excreted in Urine (feu)

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

  At designated time points (Up to ~ 23 days)

• Cumulative feu

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

  At designated time points (Up to ~ 23 days)

• Amount Excreted in Feces (Aef)

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

  At designated time points (Up to ~ 23 days)

• Cumulative Aef

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

  At designated time points (Up to ~ 23 days)

• Cumulative Fef

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

  At designated time points (Up to ~ 23 days)

• AUC0-t

  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.

  At designated time points (Up to ~ 23 days)

• AUC0-infinity

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

  At designated time points (Up to ~ 23 days)

• Maximum Plasma Concentration (Cmax)

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

  At designated time points (Up to ~ 23 days)

• Half-life t1/2

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

  At designated time points (Up to ~ 23 days)

• Time to Maximum Plasma Concentration (Tmax),

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

  At designated time points (Up to ~ 23 days)

• Apparent Total Clearance (CL; MK-5475 only)

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

  At designated time points (Up to ~ 23 days)

• Apparent Volume of Distribution (Vz; MK-5475 only)

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

  At designated time points (Up to ~ 23 days)

• AUC0-infinity Plasma [14C]MK-5475/Total Radioactivity Ratio

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

  At designated time points (Up to ~ 23 days)

Secondary Outcomes (2)

• 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

Study Arms (1)

[14C] MK-5475

EXPERIMENTAL

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

Drug: [14C] MK-5475

Interventions

[14C] MK-5475 DRUG

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

[14C] MK-5475

Eligibility Criteria

• Age: 18 Years - 50 Years
• Gender Eligibility Details: Healthy adult male participants
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Is in good health.
• Body mass index (BMI) \>18 and ≤32 kg/m2, inclusive.

You may not qualify if:

• Has history of clinically significant endocrine, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
• Has significant multiple and/or severe allergies, or has had an anaphylactic reaction or significant intolerability to prescription or nonprescription drugs or food.
• Has had a major surgery and/or donated or lost 1 unit of blood (approximately 500 mL) or blood products within 4 weeks prior to the prestudy (screening).
• Has history of exposure to significant diagnostic or therapeutic radiation or current employment in a job requiring radiation exposure monitoring within 12 months prior to check-in.
• Has participated in more than 3 radiolabeled drug studies in the last 12 months.

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Labcorp Clinical Research Unit Inc. (Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Publications (1)

• Menzel K, Liang Y, Chen B, Li D, Cislak D, Bajwa EK. An Intravenous Study with the Radiolabeled sGC Stimulator Frespaciguat to Assess PK, Metabolism, and Mass Balance. J Clin Pharmacol. 2025 Nov;65(11):1561-1567. doi: 10.1002/jcph.70066. Epub 2025 Jun 19.

  PMID: 40534306 RESULT

Related Links

• Merck Clinical Trials Information

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2025
• First Posted: January 16, 2025
• Study Start: August 15, 2022
• Primary Completion: September 30, 2022
• Study Completion: October 25, 2022
• Last Updated: October 29, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share

Locations

US (1)