The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)
- Registration Number
- NCT06658652
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 34
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
The key exclusion criteria include but are not limited to the following:
- Has history of gastrointestinal disease which may affect food and drug absorption
- Has history of cancer (malignancy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Enlicitide Decanoate Food Effect Enlicitide decanoate Participants will be administered enlicitide decanoate on Day 1 with or without food. Enlicitide Decanoate Water Effect Enlicitide decanoate Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Celerion (Site 0001)
🇺🇸Lincoln, Nebraska, United States