Clinical trial NCT06658652: The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)
Official title: A Clinical Study to Evaluate the Effect of Food and Water Volume on the Pharmacokinetics of the MK-0616 Final Market Formulation 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: 2024-10-26
Enrollment: 34
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: 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.


Eligibility criteria: 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 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).

Primary outcomes:
measure: Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 24 hours postdose
measure: Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Lag Time (tlag) of Enlicitide Decanoate in Plasma
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Apparent Terminal Half-life (t1/2) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Apparent Clearance (CL/F) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
measure: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Decanoate
timeFrame: Pre-dose and at designated time points up to 1 week postdose
Secondary outcomes:
measure: Number of Participants Who Experience an Adverse Event (AE)
timeFrame: Up to 14 days postdose
measure: Number of Participants Who Discontinue Study Due to an AE
timeFrame: Up to 14 days postdose
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: