Healthy
Conditions
Brief summary
The goal of this study is to learn what happens to a single dose of enlicitide over time in a healthy participant's body when the participant is given a single dose of MK-7262 and what happens to a single dose of MK-7262 over time in a healthy participant's body when the participant is given a single dose of enlicitide.
Interventions
DRUGMK-7262
Oral administration
DRUGEnlicitide
Oral administration
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
The main inclusion criteria include but are not limited to the following: * Is in good health before randomization * Has a body mass index (BMI) ≥18 and ≤32 kg/m\^2, inclusive
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to Infinity (AUC0-inf) of MK-7262 | Predose and at designated time points post-dose (up to 8 days) | Blood samples will be collected at multiple time points to estimate the AUC0-inf of MK-7262. |
| AUC0-inf of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the AUC0-inf of enlicitide. |
| Maximum Plasma Concentration (Cmax) of MK-7262 | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the steady-state Cmax of MK-7262. |
| Cmax of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the steady-state Cmax of enlicitide. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration-Time Curve From Time 0 to 24 hours (AUC0-24) of MK-7262 | Predose and at designated time points post-dose (up to 24 hours post-dose) | Blood samples will be collected at multiple time points to estimate the AUC0-24 of MK-7262. |
| Area Under the Concentration-Time Curve From Time 0 to Last Quantifiable Sample (AUC0-last) of MK-7262 | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the AUC0-last of MK-7262. |
| Time to Maximum Plasma Concentration (Tmax) of MK-7262 | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the Tmax of MK-7262. |
| Apparent Terminal Half-life (t1/2) of MK-7262 | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the t1/2 of MK-7262. |
| Apparent Clearance (CL/F) of MK-7262 | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the CL/F of MK-7262. |
| Apparent Volume of Distribution During Terminal Phase (Vz/F)of MK-7262 | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the Vz/F of MK-7262. |
| AUC0-24 of Enlicitide | Predose and at designated time points post-dose (up to 24 hours post-dose) | Blood samples will be collected at multiple time points to estimate the AUC0-24 of enlicitide. |
| AUC0-last of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the AUC0-last of enlicitide. |
| Tmax of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the Tmax of enlicitide. |
| t1/2 of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the t1/2 of enlicitide. |
| CL/F of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the CL/F of enlicitide. |
| Vz/F of Enlicitide | Predose and at designated time points post-dose (up to 8 days post-dose) | Blood samples will be collected at multiple time points to estimate the Vz/F of enlicitide. |
| Number of Participants Who Experience One or More Adverse Events (AEs) | Up to approximately 8 weeks | 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 that experience AEs will be reported. |
| Number of Participants Who Discontinue Study Due to an AE | Up to approximately 6 weeks | 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 that discontinue study intervention 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