Healthy
Conditions
Brief summary
The goal of the study is to learn what happens to different forms of enlicitide medications in a healthy person's body over time. Researchers will compare the amount of enlicitide in the healthy person's body over time when enlicitide is given in different formulations.
Interventions
DRUGEnlicitide
Oral Tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior * Has body mass index (BMI) ≥18 kg/m\^2 and ≤32 kg/m\^2
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve from Time 0 to 24 hours (AUC0-24hrs) of enlicitide in plasma | Pre-dose and at designated time points up to 24 hours post dose | Blood samples will be collected to determine the AUC0-24hr of enlicitide. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | 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 in plasma | Pre-dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the AUC0-Inf of enlicitide. |
| Maximum Plasma Concentration (Cmax) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the Cmax of enlicitide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 14 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. 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 8 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. The number of participants who discontinue study treatment due to an AE will be reported. |
Countries
United States
Outcome results
None listed