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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-10-21

Study Completion Date

2025-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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Enlicitide Treatment A

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral Tablet

Enlicitide Treatment B

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral Tablet

Enlicitide Treatment C

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral Tablet

Enlicitide Treatment D

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

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral Tablet

Interventions

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Enlicitide

Oral Tablet

Intervention Type DRUG

Other Intervention Names

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MK-0616 enlicitide decanoate

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes