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

October 1, 2024 updated by: Merck Sharp & Dohme LLC

A Clinical Study to Evaluate the Effect of MK-0616 on the Pharmacokinetics of Levothyroxine in Healthy Adult Participants

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

28

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nebraska
      • Lincoln, Nebraska, United States, 68502
        • Celerion (Site 0001)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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

  • 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:

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

  • History of cardiovascular disease or diabetes mellitus
  • History of cancer

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Levothyroxine
Participants will receive a single oral dose of levothyroxine.
Drug: Levothyroxine
single oral dose
Other Names:
  • Synthroid
Experimental: 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.
Drug: Levothyroxine
single oral dose
Other Names:
  • Synthroid
Drug: Enlicitide Decanoate
single oral dose
Other Names:
  • MK-0616

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
Time Frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4).
At designated timepoints (up to approximately 48 hours postdose)
Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)
Time Frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Cmax of Levothyroxine (T4).
At designated timepoints (up to approximately 48 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)
Time Frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Tmax of Levothyroxine (T4).
At designated timepoints (up to approximately 48 hours postdose)
Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)
Time Frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3).
At designated timepoints (up to approximately 48 hours postdose)
Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)
Time Frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Cmax of triiodothyronine (T3).
At designated timepoints (up to approximately 48 hours postdose)
Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)
Time Frame: At designated timepoints (up to approximately 48 hours postdose)
Blood samples will be collected to determine the Tmax of triiodothyronine (T3).
At designated timepoints (up to approximately 48 hours postdose)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
Time Frame: Up to approximately 7 weeks
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who experience a TEAE will be reported.
Up to approximately 7 weeks
Number of Participants Who Discontinue Study Due to a TEAE
Time Frame: Up to approximately 7 weeks
An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who discontinue study due to a TEAE will be reported.
Up to approximately 7 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Collaborators

Celerion

Investigators

  • Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 8, 2024

Primary Completion (Actual)

August 19, 2024

Study Completion (Actual)

September 11, 2024

Study Registration Dates

First Submitted

October 1, 2024

First Submitted That Met QC Criteria

October 1, 2024

First Posted (Actual)

October 3, 2024

Study Record Updates

Last Update Posted (Actual)

October 3, 2024

Last Update Submitted That Met QC Criteria

October 1, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • 0616-028
  • MK-0616-028 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

http://engagezone.msd.com/doc/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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