Healthy
Conditions
Brief summary
This goal of this trial is to learn about two medicines, enlicitide and rosuvastatin, in healthy people. Researchers will compare the amounts of enlicitide and rosuvastatin in a person's body over time, when they are given as separate medicines and when they are combined into one tablet.
Interventions
DRUGMK-0616A
Enlicitide/rosuvastatin fixed dose combination (FDC) or enlicitide/rosuvastatin FDC formulation B oral tablets
DRUGEnlicitide
Oral tablet
DRUGRosuvastatin
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
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Is medically healthy with no clinically significant medical history * Is a non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to study entry
Exclusion criteria
* Is unable to refrain from or anticipates the use of any drugs, including prescription and non-prescription medications, herbal remedies, or vitamin supplements beginning 14 days prior to study entry * Is a female participant of childbearing potential
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| AUC0-Inf of Rosuvastatin | Pre dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the AUC0-inf of rosuvastatin in plasma |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitde | Pre dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the AUC0-last of enlicitide in plasma |
| AUC0-Last of Rosuvastatin | Pre dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the AUC0-last of rosuvastatin in plasma |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide | Pre dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the AUC0-inf of enlicitide in plasma |
| Maximum Plasma Concentration (Cmax) of Enlicitide | Pre dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the cmax of enlicitide in plasma |
| Cmax of Rosuvastatin | Pre dose and at designated time points up to 168 hours post dose | Blood samples will be collected to determine the cmax of rosuvastatin in plasma |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Experience an Adverse Event (AE) | Up to approximately 9 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 who experience an AE will be reported. |
| Number of Participants Who Discontinue Study Treatment Due to an AE | Up to approximately 8 days after first dose | 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
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed