Healthy, Hypercholesterolemia
Conditions
Brief summary
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.
Interventions
BIOLOGICALEnlicitide Chloride
Oral administration
OTHERPlacebo
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health based on medical history, physical examination, vital signs (VS) measurements, electrocardiograms (ECGs), and laboratory safety tests performed before randomization * Has a body mass index (BMI)≥18 and ≤32 kg/m\^2
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 56 days | 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. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 42 days | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration 24 Hours Postdose (C24) of Enlicitide Chloride | At designated timepoints (up to approximately 1 week) | Blood samples will be collected to determine the C24 of enlicitide chloride. |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Chloride | At designated timepoints (up to approximately 1 week) | Blood samples will be collected to determine the Tmax of enlicitide chloride. |
| Area Under the Curve from Time 0 to 24 Hours (AUC0-24) of Enlicitide Chloride | At designated timepoints (up to approximately 24 hours) | Blood samples will be collected to determine the AUC0-24 of enlicitide chloride. |
| Percent Change from Baseline of Plasma Low Density Lipoprotein (LDL-C) Concentration After Administration of Enlicitide Chloride | Baseline, Week 1 | Blood samples will be collected to determine the LDL-C of enlicitide chloride. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Chloride | At designated timepoints (up to approximately 1 week) | Blood samples will be collected to determine the AUC0-Last of enlicitide chloride. |
| Maximum Plasma Concentration (Cmax) of Enlicitide Chloride | At designated timepoints (up to approximately 1 week) | Blood samples will be collected to determine the Cmax of enlicitide chloride. |
Countries
United States
Outcome results
None listed