NCT06658652

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 34 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Accepted

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.

Conditions

• Healthy

Interventions

Type	Name	Description
DRUG	Enlicitide decanoate	Oral tablet

Timeline

• Start date: 2023-10-24
• Primary completion: 2023-12-26
• Completion: 2023-12-26
• First posted: 2024-10-26
• Last updated: 2024-10-26

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study