The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)

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

A Clinical Study to Evaluate the Effect of Food and Water Volume on the Pharmacokinetics of the MK-0616 Final Market Formulation in Healthy Adult Participants

Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection.

The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

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:

The key inclusion criteria include but are not limited to the following:

  • Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m^2
  • Is medically healthy with no clinically significant medical history

Exclusion Criteria:

The key exclusion criteria include but are not limited to the following:

  • Has history of gastrointestinal disease which may affect food and drug absorption
  • Has 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 Food Effect
Participants will be administered enlicitide decanoate on Day 1 with or without food.
Drug: Enlicitide decanoate
Oral tablet
Other Names:
  • MK-0616
Experimental: Enlicitide Decanoate Water Effect
Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.
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 Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 24 hours postdose
Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Pre-dose and at designated time points up to 24 hours postdose
Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Lag Time (tlag) of Enlicitide Decanoate in Plasma
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Apparent Clearance (CL/F) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate
Time Frame: Pre-dose and at designated time points up to 1 week postdose
Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
Pre-dose and at designated time points up to 1 week postdose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience an Adverse Event (AE)
Time Frame: Up to 14 days postdose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported.
Up to 14 days postdose
Number of Participants Who Discontinue Study Due to an AE
Time Frame: Up to 14 days postdose
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported.
Up to 14 days postdose

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)

October 24, 2023

Primary Completion (Actual)

December 26, 2023

Study Completion (Actual)

December 26, 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

  • 0616-022
  • MK-0616 (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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