Healthy
Conditions
Brief summary
The goal of this study is to learn what happens to enlicitide (MK-0616) in a healthy person's body over time (pharmacokinetic or PK study). Researchers also want to learn about the safety of enlicitide and if people tolerate it.
Interventions
DRUGEnlicitide
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The key inclusion criteria include but are not limited to the following: * Is in good health * Has a body-mass index (BMI) between 18 and 32 kg/m\^2
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide | At designated timepoints up to approximately 50 days | Blood samples will be collected to determine the AUC0-Last of enlicitide. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of enlicitide | At designated timepoints up to approximately 50 days | Blood samples will be collected to determine the AUC0-Inf of enlicitide. |
| Maximum Plasma Concentration (Cmax) of enlicitide | At designated timepoints up to approximately 50 days | Blood samples will be collected to estimate Cmax of enlicitide. |
Secondary
| 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 clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
| Number of Participants Who Discontinue Study Intervention Due to an AE | Up to approximately 56 days | 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a study intervention. |
Countries
United States
Contacts
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed