Healthy
Conditions
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
Interventions
DRUGLevothyroxine
single oral dose
single oral dose
Sponsors
Celerion
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 50 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of Triiodothyronine (total T3) | At designated timepoints (up to approximately 48 hours postdose) | Blood samples will be collected to determine the Tmax of triiodothyronine (T3). |
| Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Triiodothyronine (total T3) | At designated timepoints (up to approximately 48 hours postdose) | Blood samples will be collected to determine the AUC0-48hr of triiodothyronine (T3). |
| Maximum Plasma Concentration (Cmax) of Triiodothyronine (total T3) | At designated timepoints (up to approximately 48 hours postdose) | Blood samples will be collected to determine the Cmax of triiodothyronine (T3). |
| Area under the Concentration-Time Curve from Time 0 to 48 hours (AUC0-48hrs) of Levothyroxine (total T4) | At designated timepoints (up to approximately 48 hours postdose) | Blood samples will be collected to determine the AUC0-48hr of Levothyroxine (T4). |
| Maximum Plasma Concentration (Cmax) of Levothyroxine (total T4) | At designated timepoints (up to approximately 48 hours postdose) | Blood samples will be collected to determine the Cmax of Levothyroxine (T4). |
| Time to Maximum Plasma Concentration (Tmax) of Levothyroxine (total T4) | At designated timepoints (up to approximately 48 hours postdose) | Blood samples will be collected to determine the Tmax of Levothyroxine (T4). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Due to a TEAE | 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. |
| Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE) | 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. |
Countries
United States
Outcome results
None listed