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

NCT ID: NCT06658652

Last Updated: 2024-10-26

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

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-24

Study Completion Date

2023-12-26

Brief Summary

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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.

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 Decanoate Food Effect

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

Group Type EXPERIMENTAL

Enlicitide decanoate

Intervention Type DRUG

Oral tablet

Enlicitide Decanoate Water Effect

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

Group Type EXPERIMENTAL

Enlicitide decanoate

Intervention Type DRUG

Oral tablet

Interventions

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Enlicitide decanoate

Oral tablet

Intervention Type DRUG

Other Intervention Names

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MK-0616

Eligibility Criteria

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Inclusion Criteria

* Has body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2
* Is medically healthy with no clinically significant medical history

Exclusion Criteria

* Has history of gastrointestinal disease which may affect food and drug absorption
* Has history of cancer (malignancy).
Minimum Eligible Age

18 Years

Maximum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Medical Director

Role: STUDY_DIRECTOR

Merck Sharp & Dohme LLC

Locations

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Celerion (Site 0001)

Lincoln, Nebraska, United States

Site Status

Countries

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United States

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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MK-0616

Identifier Type: OTHER

Identifier Source: secondary_id

0616-022

Identifier Type: -

Identifier Source: org_study_id

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