Healthy
Conditions
Brief summary
The goal of this trial is to learn what happens to different formulations (types) of enlicitide in a healthy person's body over time. Researchers will compare the amount of enlicitide in a healthy person's body over time when different formulations are given on an empty stomach and after a high-fat meal.
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
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Is in good health * Has a body-mass index (BMI) between ≥18.0 and ≤32.0 kg/m\^2
Exclusion criteria
* Has history of gastrointestinal (GI) disease which might affect food and drug absorption or has had gastric bypass or similar surgery. Examples of GI disease include (but are not limited to) recurrent vomiting, inflammatory bowel disease, chronic intestinal disease accompanied by a disturbance in digestion and absorption, Roemheld's syndrome, and severe hernia * Has a history of cancer (malignancy) * Has positive results for human immunodeficiency virus (HIV), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) * Is lactose intolerant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Plasma Concentration-Time Curve From Time Zero to Infinity (AUC0-inf) of Enlicitide in Plasma | Pre-dose and at designated timepoints (up to 168 hours post dose) | Blood samples will be collected to determine the AUC0-inf of enlicitide. |
| Maximum Observed Plasma Concentration (Cmax) of Enlicitide in Plasma | Pre-dose and at designated timepoints (up to 168 hours post dose) | Blood samples will be collected to determine the Cmax of enlicitide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-inf of Enlicitide in Plasma Under Fed vs Fasted Conditions | Pre-dose and at designated timepoints (up to 168 hours post dose) | Blood samples will be collected to determine the AUC0-inf of enlicitide under fed and fasted conditions. |
| Cmax of Enlicitide in Plasma Under Fed vs Fasted Conditions | Pre-dose and at designated timepoints (up to 168 hours post dose) | Blood samples will be collected to determine the Cmax of enlicitide under fed and fasted conditions. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 98 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 98 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
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed