Healthy
Conditions
Brief summary
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.
Interventions
Oral Capsule
DRUGPlacebo
Placebo oral capsule matching enlicitide chloride
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)
Masking description
Additional Roles Masked: Sponsor
Eligibility
Sex/Gender
MALE
Age
18 Years to 50 Years
Healthy volunteers
Yes
Inclusion criteria
Inclusion criteria include, but are not limited to: * Is in good health * Has a body mass index ≥19.0 and ≤26.0 kg/m\^2, inclusive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 2 months | 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 |
| Number of Participants Who Discontinue the Study Treatment Due to an AE | Up to approximately 2 months | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Panels A and B: Area Under the Concentration-Time Curve from 0 to Last Measurable Concentration (AUC0-last) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the AUC0-last of enlicitide chloride |
| Panels A and B: Maximum Plasma Concentration (Cmax) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the Cmax of enlicitide chloride |
| Panels A and B: Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the Tmax of enlicitide chloride |
| Panels A and B: Concentration at 24 Hours Postdose (C24) of Enlicitide Chloride | 24 hours postdose | Blood samples will be collected to determine the C24 of enlicitide chloride |
| Panels A and B: Apparent Terminal Half-Life (t1/2) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the apparent terminal t1/2 of enlicitide chloride |
| Panels A and B: Apparent Clearance (CL/F) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the CL/F of enlicitide chloride |
| Panels A and B: Apparent Volume of Distribution During Terminal Phase (Vz/F) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the Vz/F of enlicitide chloride |
| Panels A and B: Percent of Reduction of Serum Low Density Lipoprotein Cholesterol (LDL-C) | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the percent of reduction of serum LDL-C |
| Panels A and B: Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of Enlicitide Chloride | Predose and at designated timepoints (up to 8 days postdose) | Blood samples will be collected to determine the AUC0-inf of enlicitide chloride |
| Panel C: Cmax of Enlicitide Chloride | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the Cmax of enlicitide chloride |
| Panel C: Tmax of Enlicitide Chloride | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the Tmax of enlicitide chloride |
| Panel C: C24 of Enlicitide Chloride | 24 hours postdose | Blood samples will be collected to determine the C24 of enlicitide chloride |
| Panel C: Apparent Terminal t1/2 of Enlicitide Chloride | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the apparent terminal t/2 of enlicitide chloride |
| Panel C: CL/F of Enlicitide Chloride | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the CL/F of enlicitide chloride |
| Panel C: Vz/F of Enlicitide Chloride | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the Vz/F of enlicitide chloride |
| Panel C: Accumulation Ratio of Enlicitide Chloride | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the accumulation ratio of enlicitide chloride |
| Panel C: Percent of Reduction of Serum LDL-C | Predose and at designated timepoints (up to 14 days postdose) | Blood samples will be collected to determine the percent of reduction of serum LDL-C |
| Panel C: AUC0-24 of Enlicitide Chloride | Predose and at designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24 of enlicitide chloride |
| Panels A and B: Area Under the Concentration-Time Curve from 0 to 24 Hours (AUC0-24) of Enlicitide Chloride | Predose and at designated timepoints (up to 24 hours postdose) | Blood samples will be collected to determine the AUC0-24 of enlicitide chloride |
Countries
China
Outcome results
None listed