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Completed

NCT Number: NCT06626464

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

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

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Labcorp Clinical Research Unit Inc. (Site 0001)

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

[14C]Elpipodect

Drug

Oral administration

Other names: MK-8189

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

  8. %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

  9. 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.

  10. %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.

  11. 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.

  12. 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.

  13. 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.

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Oct 3, 2024
Registry last updated
Apr 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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