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A Clinical Trial of Enlicitide and Rosuvastatin in Healthy Adults (MK-0616-039)

NCT ID: NCT07300280

Last Updated: 2025-12-23

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

NOT_YET_RECRUITING

Clinical Phase

PHASE1

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-29

Study Completion Date

2026-02-17

Brief Summary

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This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.

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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Enclidite + Rosuvastatin

Participants will receive a single dose of enlicitide tablet coadministered with a single dose of rosuvastatin tablet

Group Type EXPERIMENTAL

Enlicitide

Intervention Type DRUG

Oral tablet

Rosuvastatin

Intervention Type DRUG

Oral tablet

MK-0616A

Participants will receive a single dose of MK-0616A

Group Type EXPERIMENTAL

MK-0616A

Intervention Type DRUG

Enlicitide/rosuvastatin fixed dose combination (FDC) oral tablet

Interventions

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MK-0616A

Enlicitide/rosuvastatin fixed dose combination (FDC) oral tablet

Intervention Type DRUG

Enlicitide

Oral tablet

Intervention Type DRUG

Rosuvastatin

Oral tablet

Intervention Type DRUG

Other Intervention Names

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enlicitide/rosuvastatin calcium MK-0616

Eligibility Criteria

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Inclusion Criteria

* Is medically healthy with no clinically significant medical history
* Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry

Exclusion Criteria

* Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry
* Is a female participant of childbearing potential
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

Related Links

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http://www.merckclinicaltrials.com

Merck Clinical Trials Information

Other Identifiers

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0616A-039

Identifier Type: -

Identifier Source: org_study_id