Healthy
Conditions
Brief summary
Enlicitide decanoate (MK-0616, the study medicine) is in a class of medicines that have been shown to reduce LDL-C. Enlicitide decanoate is different from the other medicines in this class because it is taken as a tablet and not an injection. The goal of this study is to see what happens to doses of enlicitide decanoate in a person's body over time. During the study, researchers will measure people's blood samples for the amount of enlicitide decanoate when taken with food or on an empty stomach, or when taken with high, medium, and low volumes of water. Researchers also want to learn about the safety of enlicitide decanoate, including how well people tolerate (manage) it.
Interventions
Oral tablet
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 the following: * Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 * Is medically healthy with no clinically significant medical history
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the Vz/F of enlicitide decanoate. |
| Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the t1/2 of enlicitide decanoate. |
| Apparent Clearance (CL/F) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the CL/F of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate | Pre-dose and at designated time points up to 24 hours postdose | Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the AUC0-last of enlicitide decanoate. |
| Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the Cmax of enlicitide decanoate. |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate | Pre-dose and at designated time points up to 1 week postdose | Blood samples will be collected to determine the Tmax of enlicitide decanoate. |
| Lag Time (tlag) of Enlicitide Decanoate in Plasma | Pre-dose and at designated time points up to 1 week postdose | Tlag is the time from dosing to the first appearance in plasma. Blood samples will be collected to determine the tlag of enlicitide decanoate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Due to an AE | Up to 14 days postdose | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who discontinue study due to an AE will be reported. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to 14 days postdose | An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. The number of participants who experience an AE will be reported. |
Countries
United States
Outcome results
None listed