The goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. The researchers want to learn about the safety of enlicitide chloride when administered at high doses.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
56
Oral administration
Oral administration
Altasciences Clinical Kansas, Inc. (Site 0002)
Overland Park, Kansas, United States
Number of Participants Who Experience an Adverse Event (AE)
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported.
Time frame: Up to approximately 56 days
Number of Participants Who Discontinue Study Treatment Due to an AE
An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who discontinue study treatment due to an AE will be reported.
Time frame: Up to approximately 42 days
Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride.
Time frame: At designated timepoints (up to approximately 24 hours)
Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Blood samples will be collected to determine the Cmax of enlicitide chloride.
Time frame: At designated timepoints (up to approximately 1 week)
Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride
Blood samples will be collected to determine the C24 of enlicitide chloride.
Time frame: At designated timepoints (up to approximately 1 week)
Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Blood samples will be collected to determine the Tmax of enlicitide chloride.
Time frame: At designated timepoints (up to approximately 1 week)
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Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-Last of enlicitide chloride.
Time frame: At designated timepoints (up to approximately 1 week)
Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride
Blood samples will be collected to determine the LDL-C of enlicitide chloride.
Time frame: Baseline, Week 1