A Clinical Study of Enlicitide Decanoate (MK-0616) in Healthy Adult Participants (MK-0616-025)
- Registration Number
- NCT06691906
- Lead Sponsor
- Merck Sharp & Dohme LLC
- Brief Summary
The purpose of this study is to learn what happens to the amount of enlicitide decanoate in the blood when enlicitide decanoate is given in different formulations.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 40
- Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing.
- Medically healthy with no clinically significant medical history.
- Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery.
- Has a history of cancer (malignancy).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Enlicitide Decanoate Treatment A Enlicitide decanoate Participants will receive a single dose of enlicitide decanoate formulation 1 on Day 1 on an empty stomach. Enlicitide Decanoate Treatment B Enlicitide decanoate Participants will receive a single dose of enlicitide decanoate formulation 2 on Day 1 on an empty stomach.
- Primary Outcome Measures
Name Time Method Area Under the Concentration-Time Curve from 0 to 24 hours (AUC0-24) of enlicitide decanoate Predose and at designated timepoints (up to 24 hours postdose) Blood samples will be collected to determine the AUC0-24 of enlicitide decanoate.
Area Under the Concentration-Time Curve from 0 to Time of Last Quantifiable Sample (AUC0-last) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the AUC0-last of enlicitide decanoate.
Area Under the Concentration-Time Curve from 0 to Infinity (AUC0-inf) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the AUC0-inf of enlicitide decanoate.
Maximum Plasma Concentration (Cmax) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the Cmax of enlicitide decanoate.
Time to Maximum Plasma Concentration (Tmax) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the Tmax of enlicitide decanoate.
Apparent Terminal Half-Life (t1/2) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the t1/2 of enlicitide decanoate.
Apparent Clearance (CL/F) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the CL/F of enlicitide decanoate.
Apparent Volume of Distribution During Terminal Phase (Vz/F) of enlicitide decanoate Predose and at designated timepoints (up to 168 hours postdose) Blood samples will be collected to determine the Vz/F of enlicitide decanoate.
- Secondary Outcome Measures
Name Time Method Number of Participants Who Experience an Adverse Event (AE) Up to approximately 44 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Number of Participants Who Discontinue Study Treatment Due to an AE Up to approximately 44 days An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.
Trial Locations
- Locations (1)
Celerion (Site 0001)
🇺🇸Lincoln, Nebraska, United States