Clinical trial NCT06772779: A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)
Official title: A Clinical Study to Evaluate the Effect of MK-0616 on Warfarin and Lisinopril Pharmacokinetics in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2025-01-14
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Maximum Plasma Concentration (Cmax) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Apparent Terminal Half-life (t½) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Apparent Clearance (CL/F) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Warfarin
timeFrame: At designated timepoints (up to approximately 2 weeks postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
measure: Area Under the Concentration-Time Curve from Time 0 to Last Measurable Concentration (AUC0-Last) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
measure: Maximum Plasma Concentration (Cmax) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
measure: Apparent Terminal Half-life (t½) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
measure: Apparent Clearance (CL/F) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Lisinopril
timeFrame: At designated timepoints (up to approximately 3 days postdose)
Secondary outcomes:
measure: Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 1
timeFrame: Up to approximately 5 weeks
measure: Number of Participants Who Discontinue Study due to a TEAE in Part 1
timeFrame: Up to approximately 5 weeks
measure: Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) in Part 2
timeFrame: Up to approximately 28 days
measure: Number of Participants Who Discontinue Study due to a TEAE in Part 2
timeFrame: Up to approximately 28 days
Other outcomes:
Locations:
city: Tempe
country: United States
facility: Celerion (Site 0001)
state: Arizona
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: