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

NCT06625814 | Completed Phase 1 FDA Drug

• 2 other identifiers: 0616-028MK-0616-028
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Healthy

Outcome Measures

Primary Outcomes (6)

• Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)

  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)

  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)

  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)

  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)

  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)

  Blood samples will be collected to determine the Tmax of triiodothyronine (T3).

  At designated timepoints (up to approximately 48 hours postdose)

Secondary Outcomes (2)

• Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)

  Up to approximately 7 weeks

• Number of Participants Who Discontinue Study Due to a TEAE

  Up to approximately 7 weeks

Study Arms (2)

Levothyroxine

EXPERIMENTAL

Participants will receive a single oral dose of levothyroxine.

Drug: Levothyroxine

Levothyroxine Plus Enlicitide Decanoate

EXPERIMENTAL

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

Drug: Levothyroxine; Drug: Enlicitide Decanoate

Interventions

Levothyroxine DRUG

single oral dose

Also known as: Synthroid

Levothyroxine; Levothyroxine Plus Enlicitide Decanoate

Enlicitide Decanoate DRUG

single oral dose

Also known as: MK-0616

Levothyroxine Plus Enlicitide Decanoate

Eligibility Criteria

• Age: 19 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead
• Celerion: collaborator

Study Sites (1)

Celerion (Site 0001)

Lincoln, Nebraska, 68502, United States

Location

Related Links

• Merck Clinical Trials Information

MeSH Terms

Interventions

Thyroxine; MK-0616

Intervention Hierarchy (Ancestors)

Thyroid Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Medical Director

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2024
• First Posted: October 3, 2024
• Study Start: July 8, 2024
• Primary Completion: August 19, 2024
• Study Completion: September 11, 2024
• Last Updated: October 3, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

US (1)