Healthy
Conditions
Brief summary
The goal of this study is to learn what happens in a person's body over time when they take enlicitide decanoate and semaglutide alone or at the same time. Enlicitide decanoate is a new medicine that lowers the amount of cholesterol in a person's blood. Semaglutide is a drug used to treat type 2 diabetes. Researchers want to learn what happens to the amount of semaglutide and enlicitide decanoate in a person's blood when each drug is taken alone and when they are taken together.
Interventions
multiple doses, oral tablet
DRUGSemaglutide
multiple doses, oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2 * Medically healthy with no clinically significant medical history
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Time to Maximum Plasma Concentration (Tmax) of Semaglutide | At designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Tmax of semaglutide. |
| Maximum Plasma Concentration (Cmax) of Semaglutide | At designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Cmax of semaglutide. |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate | At designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Tmax of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide | At designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24hrs of semaglutide. |
| Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | At designated timepoints (up to approximately 2 weeks postdose) | Blood samples will be collected to determine the Cmax of enlicitide decanoate. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Discontinue Study Due to a TEAE | Up to approximately 12 weeks | An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after 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 12 weeks | An adverse event (AE) means any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE will be considered treatment-emergent if the onset date and time is at the time of or after first study drug administration. The number of participants who experience a TEAE will be reported. |
Countries
United States
Outcome results
None listed