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OpenTrials
Completed

NCT Number: NCT06658626

A Study to Evaluate the Metabolism, Excretion, and Mass Balance of [¹⁴C]Enlicitide Chloride ([¹⁴C]MK-0616) in Healthy Participants (MK-0616-016)

The purpose of this study is to learn what happens to enlicitide chloride labeled with [¹⁴C] in a person's body over time. A label can be added to a study medicine to trace it in a person's body.

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Key information

Conditions

Healthy

Age range

18 year–60 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

  • Is in good health.
  • Has a body mass index ≥18 and ≤32 kg/m^2, inclusive.

Exclusion criteria

  • Has a history of cancer.
  • Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus.

Treatment and study plan

[¹⁴C]Enlicitide chloride

Drug

IV Injection

Other names: MK-0616

Primary outcomes

  1. Cumulative Amount of Radioactivity Excreted in Urine (Aeu)

    Time frame: At designated timepoints (up to 15 days)

    Urine samples will be collected to determine the Aeu of [¹⁴C]enlicitide chloride.

  2. Cumulative Amount of Radioactivity Excreted in Feces (Aef)

    Time frame: At designated timepoints (up to 15 days)

    Fecal samples will be collected to determine the Aef of [¹⁴C]enlicitide chloride.

  3. Cumulative Percentage of Radioactivity Excreted in Urine (feu)

    Time frame: At designated timepoints (up to 15 days)

    Urine samples will be collected to determine the feu of [¹⁴C]enlicitide chloride.

  4. Cumulative Percentage of Radioactivity Excreted in Feces (fef)

    Time frame: At designated timepoints (up to 15 days)

    Fecal samples will be collected to determine the fef of [¹⁴C]enlicitide chloride.

  5. Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to the Last Measurable Concentration (AUC0-t)

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the AUC0-t of enlicitide chloride.

  6. Plasma Enlicitide Chloride: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-inf)

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the AUC0-inf of enlicitide chloride.

  7. Plasma Enlicitide Chloride: Maximum Plasma Concentration (Cmax)

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the Cmax of enlicitide chloride.

  8. Plasma Enlicitide Chloride: Apparent Terminal Half-life (t1/2)

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the t1/2 of enlicitide chloride.

  9. Plasma Enlicitide Chloride: Time to Maximum Plasma Concentration (Tmax)

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the Tmax of enlicitide chloride.

  10. Plasma Total Reactivity: AUC0-t

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the AUC0-t of total reactivity.

  11. Plasma Total Reactivity: AUC0-inf

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the AUC0-inf of total reactivity.

  12. Plasma Total Reactivity: Cmax

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the Cmax of total reactivity.

  13. Plasma Total Reactivity: t1/2

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the t1/2 of total reactivity.

  14. Plasma Total Reactivity: Tmax

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the Tmax of total reactivity.

  15. Enlicitide Chloride to Total Radioactivity Ratio of Area Under the Concentration-Time Curve from Time 0 to the Last Detectable Sample (enlicitide chloride AUC0-x/total radioactivity AUC0-x)

    Time frame: At designated timepoints (up to 15 days)

    Plasma samples will be collected to determine the enlicitide chloride AUC0-x/total radioactivity AUC0-x.

Secondary outcomes

  1. Number of Participants Who Experience an Adverse Event (AE)

    Time frame: Up to approximately 29 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

  2. Number of Participants Who Discontinue the Study Due to an AE

    Time frame: Up to approximately 29 days

    An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-0616 in Healthy Participants

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Oct 26, 2024
Registry last updated
Oct 26, 2024

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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