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

NCTNCT06772779Other id0616-026Other idMK-0616-026

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Overview

Status: Completed
Phase: Phase 1
Enrollment: 36 participants (actual)
Sponsor: Merck Sharp & Dohme LLC · Industry
Design: Randomized · Open label (no masking)
Countries: 1 country
United States
Start: 1 Apr 2024
Primary completion: 4 Jun 2024
Completion: 4 Jun 2024
First posted: 14 Jan 2025
Last update posted: 15 Jan 2025
Conditions: Healthy

Timeline

1 trial · 1 completed

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

20242025

Ph 1
A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)
NCT06772779
1 Apr 2024 to 4 Jun 2024

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

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.

Interventions

WarfarinDrug
Enlicitide DecanoateDrug
LisinoprilDrug

Arms2

Experimental
Warfarin Plus Enlicitide Decanoate
Participants receive oral warfarin and oral enlicitide decanoate.
Experimental
Lisinopril Plus Enlicitide Decanoate
Participants receive oral lisinopril and oral enlicitide decanoate.

Primary outcomes14

Outcomes the sponsor listed as primary.

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)
Registry description
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
Time frame · At designated timepoints (up to approximately 2 weeks postdose)
Registry description
Blood samples will be collected to determine the AUC0-Last of warfarin.
Maximum Plasma Concentration (Cmax) of Warfarin
Time frame · At designated timepoints (up to approximately 2 weeks postdose)
Registry description
Blood samples will be collected to determine the Cmax of warfarin.
Time to Maximum Plasma Concentration (Tmax) of Warfarin
Time frame · At designated timepoints (up to approximately 2 weeks postdose)
Registry description
Blood samples will be collected to determine the Tmax of warfarin.
Apparent Terminal Half-life (t½) of Warfarin
Time frame · At designated timepoints (up to approximately 2 weeks postdose)
Registry description
Blood samples will be collected to determine the t½ of warfarin.
Apparent Clearance (CL/F) of Warfarin
Time frame · At designated timepoints (up to approximately 2 weeks postdose)
Registry description
Blood samples will be collected to determine the CL/F of warfarin.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin
Time frame · At designated timepoints (up to approximately 2 weeks postdose)
Registry description
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
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
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
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
Blood samples will be collected to determine the AUC0-Last of lisinopril.
Maximum Plasma Concentration (Cmax) of Lisinopril
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
Blood samples will be collected to determine the Cmax of lisinopril.
Time to Maximum Plasma Concentration (Tmax) of Lisinopril
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
Blood samples will be collected to determine the Tmax of lisinopril.
Apparent Terminal Half-life (t½) of Lisinopril
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
Blood samples will be collected to determine the t½ of lisinopril.
Apparent Clearance (CL/F) of Lisinopril
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
Blood samples will be collected to determine the CL/F of lisinopril.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril
Time frame · At designated timepoints (up to approximately 3 days postdose)
Registry description
Blood samples will be collected to determine the Vz/F of lisinopril.

Secondary outcomes(4)

Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1
Time frame · Up to approximately 5 weeks
Registry description
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
Time frame · Up to approximately 5 weeks
Registry description
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
Time frame · Up to approximately 28 days
Registry description
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
Time frame · Up to approximately 28 days
Registry description
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.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

No results are posted for this trial.

Completed trials do not always post results.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 55 Years
Healthy volunteers: Accepted

Inclusion and exclusion criteria, as posted

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

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