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OpenTrials
Completed

NCT Number: NCT06625814

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

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

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Key information

Conditions

Healthy

Age range

19 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Levothyroxine

Drug

single oral dose

Other names: Synthroid

Enlicitide Decanoate

Drug

single oral dose

Other names: MK-0616

Primary outcomes

  1. 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).

  2. 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).

  3. 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).

  4. 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).

  5. 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).

  6. 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).

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Celerion

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 3, 2024
Registry last updated
Oct 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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