Healthy
Conditions
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.
Interventions
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed