A Clinical Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Healthy

Treatments: Drug: Enlicitide

Study type: Interventional

Funder types: Industry

Identifiers

NCT06609512

0616-033

MK-0616-033 (Other Identifier)

Details and patient eligibility

About

The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as "enlicitide" throughout.

Enrollment: 20 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

The main inclusion criteria include but are not limited to the following:

• Has body mass index (BMI) ≥18 kg/m^2 and ≤32 kg/m^2

Exclusion criteria

The main exclusion criteria include but are not limited to the following:

• History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
• History of cancer (malignancy)
• Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
• History of a major surgery
• Is lactose intolerant

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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20 participants in 4 patient groups

Enlicitide Treatment A

Experimental group

Description:

Participants receive single oral dose of enlicitide after 8-hour overnight fast.

Treatment:

Drug: Enlicitide

Enlicitide Treatment B

Experimental group

Description:

Participants receive single oral dose of enlicitide 4 hours after morning meal.

Treatment:

Drug: Enlicitide

Enlicitide Treatment C

Experimental group

Description:

Participants receive single oral dose of enlicitide 3 hours after morning meal.

Treatment:

Drug: Enlicitide

Enlicitide Treatment D

Experimental group

Description:

Participants receive single oral dose of enlicitide 2 hours after morning meal.

Treatment:

Drug: Enlicitide