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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
38
multiple doses, oral tablet
multiple doses, oral tablet
Celerion (Site 0001)
Lincoln, Nebraska, United States
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Enlicitide Decanoate
Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate.
Time frame: At designated timepoints (up to 24 hours postdose)
Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of Semaglutide
Blood samples will be collected to determine the AUC0-24hrs of semaglutide.
Time frame: At designated timepoints (up to 24 hours postdose)
Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate
Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Maximum Plasma Concentration (Cmax) of Semaglutide
Blood samples will be collected to determine the Cmax of semaglutide.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate
Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Time to Maximum Plasma Concentration (Tmax) of Semaglutide
Blood samples will be collected to determine the Tmax of semaglutide.
Time frame: At designated timepoints (up to approximately 2 weeks postdose)
Number of Participants Who Experience a Treatment-Emergent Adverse Event (TEAE)
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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.
Time frame: Up to approximately 12 weeks
Number of Participants Who Discontinue Study Due to a TEAE
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.
Time frame: Up to approximately 12 weeks