A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

February 6, 2025 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Effect of Fasting Duration on the Pharmacokinetics of the Enlicitide in Healthy Adult Participants

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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
    • Arizona
      • Tempe, Arizona, United States, 85283
        • 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 main inclusion criteria include but are not limited to the following:

- Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion Criteria:

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

  • History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
  • History of cancer (malignancy)
  • Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
  • History of a major surgery
  • Is lactose intolerant

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 Treatment A
Participants receive single oral dose of enlicitide after 8-hour overnight fast.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • enlicitide decanoate
Experimental: Enlicitide Treatment B
Participants receive single oral dose of enlicitide 4 hours after morning meal.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • enlicitide decanoate
Experimental: Enlicitide Treatment C
Participants receive single oral dose of enlicitide 3 hours after morning meal.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • enlicitide decanoate
Experimental: Enlicitide Treatment D
Participants receive single oral dose of enlicitide 2 hours after morning meal.
Drug: Enlicitide
Oral Tablet
Other Names:
  • MK-0616
  • enlicitide decanoate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
AUC0-inf of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 24 hours post dose
AUC0-24 of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 24 hours post dose
Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
AUC0-last of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Maximum plasma concentration (Cmax) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
Cmax of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Time to maximum plasma concentration (Tmax) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
Tmax of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Apparent terminal half-life (t1/2) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
t1/2 of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Apparent Clearance (CL/F) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
CL/F of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
Vz/F of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose
Lag Time (tlag) of enlicitide in plasma
Time Frame: Pre-dose and at designated time points up to 168 hours post dose
tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined.
Pre-dose and at designated time points up to 168 hours post dose

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants who experience one or more adverse events (AEs)
Time Frame: Up to ~ 14 days
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.
Up to ~ 14 days
Number of participants who discontinue study intervention due to an AE
Time Frame: Up to ~ 14 days
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.
Up to ~ 14 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)

October 21, 2024

Primary Completion (Actual)

January 13, 2025

Study Completion (Actual)

January 31, 2025

Study Registration Dates

First Submitted

September 20, 2024

First Submitted That Met QC Criteria

September 20, 2024

First Posted (Actual)

September 24, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 6, 2025

Last Verified

February 1, 2025

More Information

Terms related to this study

Other Study ID Numbers

  • 0616-033
  • MK-0616-033 (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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