The purpose of this study is to learn about the safety of enlicitide chloride and how well people tolerate it. Researchers also want to learn what happens to different amounts of enlicitide chloride in a healthy person's body over time.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
DOUBLE
Enrollment
37
Oral Capsule
Placebo oral capsule matching enlicitide chloride
Zhongshan Hospital,Fudan University-Dep. of Clinical Pharmacology (Site 0001)
Shanghai, Shanghai Municipality, China
Number of Participants Who Experience an Adverse Event (AE)
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
Time frame: Up to approximately 2 months
Number of Participants Who Discontinue the Study Treatment Due to an AE
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
Time frame: Up to approximately 2 months
Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-inf of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 24 hours postdose)
Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-last of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride
Blood samples will be collected to determine the Cmax of enlicitide chloride
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Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride
Blood samples will be collected to determine the Tmax of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride
Blood samples will be collected to determine the C24 of enlicitide chloride
Time frame: 24 hours postdose
Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride
Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride
Blood samples will be collected to determine the CL/F of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride
Blood samples will be collected to determine the Vz/F of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C)
Blood samples will be collected to determine the percent of reduction of serum LDL-C
Time frame: Predose and at designated timepoints (up to 8 days postdose)
Panel C: AUC0-24 of Enlicitide Chloride
Blood samples will be collected to determine the AUC0-24 of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 24 hours postdose)
Panel C: Cmax of Enlicitide Chloride
Blood samples will be collected to determine the Cmax of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Tmax of Enlicitide Chloride
Blood samples will be collected to determine the Tmax of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: C24 of Enlicitide Chloride
Blood samples will be collected to determine the C24 of enlicitide chloride
Time frame: 24 hours postdose
Panel C: Apparent Terminal t1/2 of Enlicitide Chloride
Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: CL/F of Enlicitide Chloride
Blood samples will be collected to determine the CL/F of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Vz/F of Enlicitide Chloride
Blood samples will be collected to determine the Vz/F of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Accumulation Ratio of Enlicitide Chloride
Blood samples will be collected to determine the accumulation ratio of enlicitide chloride
Time frame: Predose and at designated timepoints (up to 14 days postdose)
Panel C: Percent of Reduction of Serum LDL-C
Blood samples will be collected to determine the percent of reduction of serum LDL-C
Time frame: Predose and at designated timepoints (up to 14 days postdose)