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

Phase 1

Completed

• Conditions: Healthy
• Interventions: Drug: Warfarin; Drug: Enlicitide Decanoate; Drug: Lisinopril

• Registration Number: NCT06772779
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-04-01
• Primary Completion: 2024-06-04
• Study Completion: 2024-06-04
• Status Verified: 2025-01
• Study First Submitted: 2025-01-09
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-13
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Warfarin Plus Enlicitide Decanoate	Warfarin	Participants receive oral warfarin and oral enlicitide decanoate.
Warfarin Plus Enlicitide Decanoate	Enlicitide Decanoate	Participants receive oral warfarin and oral enlicitide decanoate.
Lisinopril Plus Enlicitide Decanoate	Lisinopril	Participants receive oral lisinopril and oral enlicitide decanoate.
Lisinopril Plus Enlicitide Decanoate	Enlicitide Decanoate	Participants receive oral lisinopril and oral enlicitide decanoate.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1	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.
Number of Participants Who Discontinue Study due to a TEAE in Part 1	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.
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2	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.
Number of Participants Who Discontinue Study due to a TEAE in Part 2	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.

Trial Locations

Locations (1)

Celerion (Site 0001); 🇺🇸 Tempe, Arizona, United States