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

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: Healthy
• Intervention / Treatment: Drug: Enlicitide Decanoate; Drug: Warfarin; Drug: Lisinopril

• Study Type: Interventional
• Enrollment (Actual): 36
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Tempe, Arizona, United States, 85283
      • Celerion (Site 0001)

Participation Criteria

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

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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	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

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

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: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protease Inhibitors; Enzyme Inhibitors; Protective Agents; Cardiotonic Agents; Anticoagulants; Antihypertensive Agents; Angiotensin-Converting Enzyme Inhibitors; Warfarin; Lisinopril
• 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