Healthy
Conditions
Brief summary
The goal of the study is to learn what happens to enlicitide decanoate in a healthy person's body over time when taken on an empty stomach or with food. Researchers will compare what happens to enlicitide in a healthy person's body over time when enlicitide is taken with or without food. Enlicitide decanoate will be referred to as enlicitide throughout.
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: \- 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 |
|---|---|---|
| Lag Time (tlag) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | tlag is the time from dosing to the first appearance in plasma. The tlag of enlicitide in plasma will be determined. |
| Apparent Clearance (CL/F) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | CL/F of enlicitide in plasma will be determined. |
| Apparent volume of distribution during terminal phase (Vz/F) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | Vz/F of enlicitide in plasma will be determined. |
| Area Under the Concentration versus Time Curve from 0 to Infinity (AUC0-inf) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | AUC0-inf of enlicitide in plasma will be determined. |
| Area Under the Concentration versus Time Curve from Time 0 to 24 hours (AUC0-24) of enlicitide in plasma | Pre-dose and at designated time points up to 24 hours post dose | AUC0-24 of enlicitide in plasma will be determined. |
| Area under the concentration versus time curve from time 0 to last quantifiable sample (AUC0-last) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | AUC0-last of enlicitide in plasma will be determined. |
| Maximum plasma concentration (Cmax) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | Cmax of enlicitide in plasma will be determined. |
| Time to maximum plasma concentration (Tmax) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | Tmax of enlicitide in plasma will be determined. |
| Apparent terminal half-life (t1/2) of enlicitide in plasma | Pre-dose and at designated time points up to 168 hours post dose | t1/2 of enlicitide in plasma will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinue study intervention due to an AE | Up to ~ 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. |
| Number of participants who experience one or more adverse events (AEs) | Up to ~ 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. |
Countries
United States
Outcome results
None listed