NCT06626464

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for phase_1 healthy

Timeline
Completed

Started May 2022

Shorter than P25 for phase_1 healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 13, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 8, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 8, 2022

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2024

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 3, 2024

Completed
Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

2 months

First QC Date

October 2, 2024

Last Update Submit

April 8, 2026

Conditions

Healthy

Outcome Measures

Primary Outcomes (13)

  • Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of Elpipodect

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    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

    Feces samples will be collected to determine the metabolites of elpipodect.

    Predose and at designated timepoints up to Day 15

Secondary Outcomes (2)

  • Number of Participants Experiencing an Adverse Event (AE)

    Up to ~ 28 days

  • Number of Participants Discontinuing Study Treatment due to an AE

    Up to ~ 28 days

Study Arms (1)

Carbon-14 radiolabeled [14C] Elpipodect

EXPERIMENTAL

Participants receive a dose of 4.5-mg immediate release (IR) (\~ 50 μCi) orally on Day 1.

Drug: [14C]Elpipodect

Interventions

[14C]ElpipodectDRUG

Oral administration

Also known as: MK-8189
Carbon-14 radiolabeled [14C] Elpipodect

Eligibility Criteria

Age18 Years - 55 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Labcorp Clinical Research Unit Inc. (Site 0001)

Madison, Wisconsin, 53704, United States

Location

Related Links

MeSH Terms

Interventions

MK-8189

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

October 2, 2024

First Posted

October 3, 2024

Study Start

May 13, 2022

Primary Completion

July 8, 2022

Study Completion

July 8, 2022

Last Updated

April 13, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will share

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

More information

Locations

US(1)