A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)

NCT ID: NCT06625814

Last Updated: 2024-10-03

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

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-08

Study Completion Date

2024-09-11

Brief Summary

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Levothyroxine (T4) is a man-made thyroid hormone used to treat certain thyroid conditions. After taking levothyroxine, a person's body changes it to triiodothyronine (T3). The amount of levothyroxine in a person's blood must be carefully controlled to maintain proper function. Enlicitide decanoate was designed to lower the amount of cholesterol in a person's blood.

Researchers want to learn about levothyroxine when taken at the same time with enlicitide decanoate. They want to:

* Measure a person's blood to find out if the amount of levothyroxine in the blood is the same when levothyroxine is taken alone or with enlicitide decanoate
* Learn about the safety of levothyroxine when taken alone or with enlicitide decanoate and if people tolerate 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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Levothyroxine

Participants will receive a single oral dose of levothyroxine.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

single oral dose

Levothyroxine Plus Enlicitide Decanoate

Participants will receive a single oral dose of levothyroxine and a single oral dose of enlicitide decanoate at the same time.

Group Type EXPERIMENTAL

Levothyroxine

Intervention Type DRUG

single oral dose

Enlicitide Decanoate

Intervention Type DRUG

single oral dose

Interventions

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Levothyroxine

single oral dose

Intervention Type DRUG

Enlicitide Decanoate

single oral dose

Intervention Type DRUG

Other Intervention Names

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Synthroid MK-0616

Eligibility Criteria

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Inclusion Criteria

* Medically healthy with no clinically significant medical history
* Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing

Exclusion Criteria

* History of cardiovascular disease or diabetes mellitus
* History of cancer
Minimum Eligible Age

19 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Celerion

INDUSTRY

Sponsor Role collaborator

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-0616-028

Identifier Type: OTHER

Identifier Source: secondary_id

0616-028

Identifier Type: -

Identifier Source: org_study_id

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