Healthy
Conditions
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.
Interventions
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
* 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.
Exclusion criteria
* Has a history of gastrointestinal disease or has had a gastric bypass or similar surgery. * Has a history of cancer (malignancy).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
Countries
United States
Outcome results
None listed