Clinical trial NCT06625814: A Study of Levothyroxine and Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-028)
Official title: A Clinical Study to Evaluate the Effect of MK-0616 on the Pharmacokinetics of Levothyroxine in Healthy Adult Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
Collaborators: name: Celerion
First posted: 2024-10-03
Enrollment: 28
Sex: ALL
Minimum age (years): 19
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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


Eligibility criteria: 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

Primary outcomes:
measure: Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4)
timeFrame: At designated timepoints (up to approximately 48 hours postdose)
measure: Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4)
timeFrame: At designated timepoints (up to approximately 48 hours postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4)
timeFrame: At designated timepoints (up to approximately 48 hours postdose)
measure: Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3)
timeFrame: At designated timepoints (up to approximately 48 hours postdose)
measure: Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3)
timeFrame: At designated timepoints (up to approximately 48 hours postdose)
measure: Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3)
timeFrame: At designated timepoints (up to approximately 48 hours postdose)
Secondary outcomes:
measure: Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
timeFrame: Up to approximately 7 weeks
measure: Number of Participants Who Discontinue Study Due to a TEAE
timeFrame: Up to approximately 7 weeks
Other outcomes:
Locations:
city: Lincoln
country: United States
facility: Celerion (Site 0001)
state: Nebraska
Study officials:
affiliation: Merck Sharp & Dohme LLC
name: Medical Director
role: STUDY_DIRECTOR
References: