The Effect of Food and Water Volume in Healthy Adult Participants Administered Enlicitide Decanoate (MK-0616) (MK-0616-022)

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06658652
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
18 Years - 55 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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.

Key Dates

Start date
Oct 24, 2023
Status verified
Oct 2024
Primary completion
Dec 26, 2023
Completion
Dec 26, 2023

Study Design

Enrollment
34 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Enlicitide Decanoate Food Effect
    Participants will be administered enlicitide decanoate on Day 1 with or without food.
  • Experimental: Enlicitide Decanoate Water Effect
    Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.

Primary Outcome Measure

Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate [ Time Frame: Pre-dose and at designated time points up to 1 week postdose ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion (Site 0001)LincolnNebraska68502-

Find similar trials in Lincoln, NE

By research site
Celerion· Lincoln, NE

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