A Study of Elpipodect (MK-8189) Human Absorption, Metabolism, and Excretion in Healthy Male Participants (MK-8189-010)

April 8, 2026 updated by: Merck Sharp & Dohme LLC

A Phase 1 Clinical Study to Evaluate the Absorption, Metabolism and Excretion of [14C]MK-8189 in Healthy Adults

The purpose of this study is to learn what happens to elpipodect in a healthy person's body over time.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

6

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53704
        • Labcorp Clinical Research Unit Inc. (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

Key inclusion criteria include but are not limited to the following:

  • Is in good health based on medical history, physical examination, VS measurements, and ECGs performed before randomization.
  • Has a BMI ≥19 and ≤32 kg/m2, inclusive, at screening

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has a history of clinically significant endocrine, gastrointestinal (GI), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major neurological (including stroke and chronic seizures) abnormalities or diseases.
  • Has a history of cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Carbon-14 radiolabeled [14C] Elpipodect
Participants receive a dose of 4.5-mg immediate release (IR) (~ 50 μCi) orally on Day 1.
Drug: [14C]Elpipodect
Oral administration
Other Names:
  • MK-8189

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Elpipodect
Time Frame: Predose and postdose up to 24 hours
Blood samples will be collected to determine the AUC0-24 of elpipodect.
Predose and postdose up to 24 hours
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUClast of elpipodect.
Predose and at designated timepoints up to Day 15
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the AUC0-inf of elpipodect.
Predose and at designated timepoints up to Day 15
Maximum Concentration (Cmax) of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Cmax of elpipodect.
Predose and at designated timepoints up to Day 15
Apparent Half Life (t½) of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the t1/2 of elpipodect.
Predose and at designated timepoints up to Day 15
Time to Reach Maximum Concentration (Tmax) of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the Tmax of elpipodect.
Predose and at designated timepoints up to Day 15
Amount Excreted (Ae) in Urine of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the Ae of elpipodect
Predose and at designated timepoints up to Day 15
%Dose Excreted in Urine of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the %dose of elpipodect
Predose and at designated timepoints up to Day 15
Amount Excreted (Ae) in Feces of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the Ae of elpipodect.
Predose and at designated timepoints up to Day 15
%Dose Excreted in Feces of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the %dose of elpipodect.
Predose and at designated timepoints up to Day 15
Metabolites in Plasma of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Blood samples will be collected to determine the metabolites of elpipodect.
Predose and at designated timepoints up to Day 15
Metabolites in Urine of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Urine samples will be collected to determine the metabolites of elpipodect.
Predose and at designated timepoints up to Day 15
Metabolites in Feces of Elpipodect
Time Frame: Predose and at designated timepoints up to Day 15
Feces samples will be collected to determine the metabolites of elpipodect.
Predose and at designated timepoints up to Day 15

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Experiencing an Adverse Event (AE)
Time Frame: Up to ~ 28 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Up to ~ 28 days
Number of Participants Discontinuing Study Treatment due to an AE
Time Frame: Up to ~ 28 days
An AE is any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study treatment. For each arm, the number of participants experiencing an AE will be assessed.
Up to ~ 28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 13, 2022

Primary Completion (Actual)

July 8, 2022

Study Completion (Actual)

July 8, 2022

Study Registration Dates

First Submitted

October 2, 2024

First Submitted That Met QC Criteria

October 2, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

April 13, 2026

Last Update Submitted That Met QC Criteria

April 8, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 8189-010
  • MK-8189-010 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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