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

October 24, 2024 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

8

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:

  • 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.

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: [¹⁴C]Enlicitide chloride
Participants will receive a single dose of [¹⁴C]enlicitide chloride on Day 1.
Drug: [¹⁴C]Enlicitide chloride
IV Injection
Other Names:
  • MK-0616

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)
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.
At designated timepoints (up to 15 days)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 29 days
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.
Up to approximately 29 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)

March 10, 2023

Primary Completion (Actual)

August 2, 2023

Study Completion (Actual)

August 2, 2023

Study Registration Dates

First Submitted

October 24, 2024

First Submitted That Met QC Criteria

October 24, 2024

First Posted (Actual)

October 26, 2024

Study Record Updates

Last Update Posted (Actual)

October 26, 2024

Last Update Submitted That Met QC Criteria

October 24, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 0616-016
  • MK-0616-016 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/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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