A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)

January 13, 2025 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Effect of MK-0616 on Warfarin and Lisinopril Pharmacokinetics in Healthy Adult Participants

The main goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate with warfarin or lisinopril. Researchers want to learn if the amount of warfarin in a person's blood is similar when warfarin is taken alone or with enlicitide decanoate.

Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Warfarin is a drug that reduces risk of blood clotting, and lisinopril is a drug that lowers blood pressure.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

36

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 key inclusion criteria include but are not limited to:

  • Is in good health
  • Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m^2

Exclusion Criteria:

The key exclusion criteria include but are not limited to:

  • History of gastrointestinal disease which may affect food or drug absorption, or has had a gastric bypass or similar surgery
  • History of cancer

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: Warfarin Plus Enlicitide Decanoate
Participants receive oral warfarin and oral enlicitide decanoate.
Drug: Enlicitide Decanoate
single oral dose
Other Names:
  • MK-0616
Drug: Warfarin
single oral dose
Other Names:
  • Jantoven
Experimental: Lisinopril Plus Enlicitide Decanoate
Participants receive oral lisinopril and oral enlicitide decanoate.
Drug: Enlicitide Decanoate
single oral dose
Other Names:
  • MK-0616
Drug: Lisinopril
single oral dose
Other Names:
  • Zestril

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 Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-Inf of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the AUC0-Last of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Maximum Plasma Concentration (Cmax) of Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Cmax of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Time to Maximum Plasma Concentration (Tmax) of Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Tmax of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Apparent Terminal Half-life (t½) of Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the t½ of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Apparent Clearance (CL/F) of Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the CL/F of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin
Time Frame: At designated timepoints (up to approximately 2 weeks postdose)
Blood samples will be collected to determine the Vz/F of warfarin.
At designated timepoints (up to approximately 2 weeks postdose)
Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the AUC0-Inf of lisinopril.
At designated timepoints (up to approximately 3 days postdose)
Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the AUC0-Last of lisinopril.
At designated timepoints (up to approximately 3 days postdose)
Maximum Plasma Concentration (Cmax) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the Cmax of lisinopril.
At designated timepoints (up to approximately 3 days postdose)
Time to Maximum Plasma Concentration (Tmax) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the Tmax of lisinopril.
At designated timepoints (up to approximately 3 days postdose)
Apparent Terminal Half-life (t½) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the t½ of lisinopril.
At designated timepoints (up to approximately 3 days postdose)
Apparent Clearance (CL/F) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the CL/F of lisinopril.
At designated timepoints (up to approximately 3 days postdose)
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril
Time Frame: At designated timepoints (up to approximately 3 days postdose)
Blood samples will be collected to determine the Vz/F of lisinopril.
At designated timepoints (up to approximately 3 days postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1
Time Frame: Up to approximately 5 weeks
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE in Part 1 will be reported.
Up to approximately 5 weeks
Number of Participants Who Discontinue Study due to a TEAE in Part 1
Time Frame: Up to approximately 5 weeks
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE in Part 1 will be reported.
Up to approximately 5 weeks
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2
Time Frame: Up to approximately 28 days
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE in Part 2 will be reported.
Up to approximately 28 days
Number of Participants Who Discontinue Study due to a TEAE in Part 2
Time Frame: Up to approximately 28 days
An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who discontinue study due to a TEAE in Part 2 will be reported.
Up to approximately 28 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)

April 1, 2024

Primary Completion (Actual)

June 4, 2024

Study Completion (Actual)

June 4, 2024

Study Registration Dates

First Submitted

January 9, 2025

First Submitted That Met QC Criteria

January 9, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 13, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0616-026
  • MK-0616-026 (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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