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

Part of paid clinical trials in Lincoln, Nebraska.

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT06625814
Phase
PHASE1
Status
Completed

Conditions

  • Healthy

Eligibility Criteria

Sex
ALL
Age
19 Years - 50 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Jul 8, 2024
Status verified
Sep 2024
Primary completion
Aug 19, 2024
Completion
Sep 11, 2024

Study Design

Enrollment
28 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Levothyroxine
    Participants will receive a single oral dose of levothyroxine.
  • 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.

Primary Outcome Measure

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) ]

Locations (1)

FacilityCityStateZIPSite coordinators
Celerion (Site 0001)LincolnNebraska68502-

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