Healthy
Conditions
Brief summary
The goal of this study is to learn what happens to enlicitide decanoate and atorvastatin in a healthy person's body over time. Researchers want to learn what happens to enlicitide decanoate in the body when it is given with and without another medicine called atorvastatin and what happens to atorvastatin in the body when it is given with or without enlicitide decanoate.
Interventions
Oral administration
DRUGAtorvastatin
Oral administration
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
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 based on participant self-reporting * Medically healthy with no clinically significant medical history, physical examination, laboratory profiles, standard and orthostatic vital signs, and electrocardiograms (ECGs)
Exclusion criteria
* History of gastrointestinal disease which may affect food and drug absorption or has had a gastric bypass or similar surgery * History of cancer (malignancy)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent Volume of Distribution (Vz/F) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the Vz/F of enlicitide decanoate. |
| Apparent Terminal Half-Life (t1/2) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the t1/2 of enlicitide decanoate. |
| Apparent Clearance (CL/F) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the CL/F of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Atorvastatin and its Metabolites | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the AUC0-Inf of atorvastatin and its metabolites. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Atorvastatin and its Metabolites | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the AUC0-Last of atorvastatin and its metabolites. |
| Maximum Plasma Concentration (Cmax) of Atorvastatin and its Metabolites | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the Cmax of atorvastatin and its metabolites. |
| Time to Maximum Plasma Concentration (Tmax) of Atorvastatin and its Metabolites | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the Tmax of atorvastatin and its metabolites. |
| Apparent Terminal Half-Life (t1/2) of Atorvastatin and its Metabolites | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the t1/2 of atorvastatin and its metabolites. |
| Apparent Clearance (CL/F) of Atorvastatin | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the CL/F of atorvastatin. |
| Apparent Volume of Distribution (Vz/F) of Atorvastatin | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the Vz/F of atorvastatin. |
| Area Under the Concentration-Time Curve from Time 0 to 24 Hours (AUC0-24hrs) of Enlicitide Decanoate | At designated timepoints (up to approximately 24 hours) | Blood samples will be collected to determine the AUC0-24hrs of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to Infinity (AUC0-Inf) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the AUC0-Inf of enlicitide decanoate. |
| Area Under the Concentration-Time Curve from Time 0 to Last (AUC0-Last) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the AUC0-Last of enlicitide decanoate. |
| Maximum Plasma Concentration (Cmax) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | Blood samples will be collected to determine the Cmax of enlicitide decanoate. |
| Time to Maximum Plasma Concentration (Tmax) of Enlicitide Decanoate | At designated timepoints (up to approximately 8 days) | 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 6 weeks | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
| Number of Participants Who Experience an Adverse Event (AE) | Up to approximately 10 weeks | An AE is any untoward medical occurrence in a participant, temporally associated with the use of study treatment, whether or not considered related to the study treatment. The number of participants who experience an AE will be reported. |
Countries
United States
Outcome results
None listed