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Completed

NCT Number: NCT06772779

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

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.

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Key information

Conditions

Healthy

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Tempe, Arizona, 85283, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Warfarin

Drug

single oral dose

Other names: Jantoven

Enlicitide Decanoate

Drug

single oral dose

Other names: MK-0616

Lisinopril

Drug

single oral dose

Other names: Zestril

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Jan 14, 2025
Registry last updated
Jan 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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