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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide decanoate

Study type: Interventional

Funder types: Industry

Identifiers

NCT06658652

0616-022

MK-0616 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

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).

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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34 participants in 2 patient groups

Enlicitide Decanoate Food Effect

Experimental group

Description:

Participants will be administered enlicitide decanoate on Day 1 with or without food.

Treatment:

Drug: Enlicitide decanoate

Enlicitide Decanoate Water Effect

Experimental group

Description:

Participants will be administered enlicitide decanoate on Day 1 with high, medium, and low volumes of water.

Treatment:

Drug: Enlicitide decanoate