A Clincal Study of Enlicitide and the Effect of Food in Healthy Adult Participants (MK-0616-033)
- Registration Number
- NCT06609512
- Lead Sponsor
- Merck Sharp & Dohme LLC
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
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
The main exclusion criteria include but are not limited to the following:
- History of gastrointestinal disease which may affect food and drug absorption, or has had a gastric bypass or similar surgery
- History of cancer (malignancy)
- Positive test(s) for Hepatitis B surface antigen (HBsAg), hepatitis C antibodies or Human immunodeficiency virus (HIV)
- History of a major surgery
- Is lactose intolerant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Enlicitide Treatment A Enlicitide Participants receive single oral dose of enlicitide after 8-hour overnight fast. Enlicitide Treatment B Enlicitide Participants receive single oral dose of enlicitide 4 hours after morning meal. Enlicitide Treatment C Enlicitide Participants receive single oral dose of enlicitide 3 hours after morning meal. Enlicitide Treatment D Enlicitide Participants receive single oral dose of enlicitide 2 hours after morning meal.
- Primary Outcome Measures
Name Time Method 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.
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.
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.
- Secondary Outcome Measures
Name Time Method 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.
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.
Trial Locations
- Locations (1)
Celerion ( Site 0001)
🇺🇸Tempe, Arizona, United States