A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)

November 13, 2024 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Relative Bioavailability of MK-0616 Formulations in Healthy Adult Participants

The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion (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:

  • Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
  • Medically healthy with no clinically significant medical history.

Exclusion Criteria:

  • Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
  • Has a history of cancer (malignancy).

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: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Enlicitide Decanoate Treatment A
Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach.
Drug: Enlicitide decanoate
Oral tablet
Other Names:
  • MK-0616
Experimental: Enlicitide Decanoate Treatment B
Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach.
Drug: Enlicitide decanoate
Oral tablet
Other Names:
  • MK-0616

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 enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 24 hours postdose)
Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Predose and at designated timepoints (up to 24 hours postdose)
Area Under the Concentration-Time Curve from 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the AUC0-inf of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)
Maximum Plasma Concentration (Cmax) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)
Apparent Terminal Half-Life (t1/2) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)
Apparent Clearance (CL/F) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of enlicitide decanoate
Time Frame: Predose and at designated timepoints (up to 168 hours postdose)
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
Predose and at designated timepoints (up to 168 hours postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to approximately 44 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 44 days
Number of Participants Who Discontinue Study Treatment Due to an AE
Time Frame: Up to approximately 44 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 44 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 18, 2024

Primary Completion (Actual)

May 1, 2024

Study Completion (Actual)

May 1, 2024

Study Registration Dates

First Submitted

November 13, 2024

First Submitted That Met QC Criteria

November 13, 2024

First Posted (Estimated)

November 18, 2024

Study Record Updates

Last Update Posted (Estimated)

November 18, 2024

Last Update Submitted That Met QC Criteria

November 13, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 0616-025
  • MK-0616-025 (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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