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

NCT06772779 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-026MK-0616-026
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Healthy

Outcome Measures

Primary Outcomes (14)

• 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 Outcomes (4)

• Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1

  Up to approximately 5 weeks

• Number of Participants Who Discontinue Study due to a TEAE in Part 1

  Up to approximately 5 weeks

• Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2

  Up to approximately 28 days

• Number of Participants Who Discontinue Study due to a TEAE in Part 2

  Up to approximately 28 days

Study Arms (2)

Warfarin Plus Enlicitide Decanoate

EXPERIMENTAL

Participants receive oral warfarin and oral enlicitide decanoate.

Drug: Warfarin; Drug: Enlicitide Decanoate

Lisinopril Plus Enlicitide Decanoate

EXPERIMENTAL

Participants receive oral lisinopril and oral enlicitide decanoate.

Drug: Enlicitide Decanoate; Drug: Lisinopril

Interventions

Warfarin DRUG

single oral dose

Also known as: Jantoven

Warfarin Plus Enlicitide Decanoate

Enlicitide Decanoate DRUG

single oral dose

Also known as: MK-0616

Lisinopril Plus Enlicitide Decanoate; Warfarin Plus Enlicitide Decanoate

Lisinopril DRUG

single oral dose

Also known as: Zestril

Lisinopril Plus Enlicitide Decanoate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Study Sites (1)

Celerion (Site 0001)

Tempe, Arizona, 85283, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Warfarin; Vitamin B 6; MK-0616; Lisinopril

Intervention Hierarchy (Ancestors)

4-Hydroxycoumarins; Coumarins; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Picolines; Pyridines; Dipeptides; Oligopeptides; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: January 14, 2025
• Study Start: April 1, 2024
• Primary Completion: June 4, 2024
• Study Completion: June 4, 2024
• Last Updated: January 15, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share

Locations

US (1)