Healthy
Conditions
Brief summary
Researchers have designed a new study medicine called enlicitide decanoate (MK-0616) as a new way to lower the amount of low-density lipoprotein cholesterol (LDL-C) in a person's blood. Enlicitide decanoate will be called enlicitide from this point forward. Lithium (also called lithium carbonate) is a medicine used in bipolar disorder. Researchers want to learn about lithium when taken at the same time with enlicitide. They want to: * Measure a person's blood to find out if the amount of lithium in the blood is the same when lithium is taken alone or with enlicitide * Learn about the safety of lithium when taken alone or with enlicitide and if people tolerate it
Interventions
DRUGlithium carbonate
Oral capsule
DRUGenlicitide
Oral tablet
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_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 key inclusion criteria include but are not limited to the following: * Is medically healthy with no clinically significant medical history * Is a continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing
Exclusion criteria
The key
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area Under the Concentration versus Time Curve From Time Zero to Last Quantifiable Sample (AUC0-last) for Lithium in Plasma | At designated timepoints (up to approximately 5 days post dose) | Blood samples will be collected to determine the AUC0-last of lithium in plasma. |
| Cmax (Maximum Concentration) for Lithium in Plasma | At designated timepoints (up to approximately 5 days post dose) | Blood samples will be collected determine the Cmax of lithium in plasma. |
| Area Under the Concentration Versus Time Curve From Time Zero to Infinity (AUC0-inf) for Lithium in Plasma | At designated timepoints (up to approximately 5 days post dose) | Blood samples will be collected to determine the AUC0-inf of lithium in plasma. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who experience a Treatment Emergent Adverse Event (TEAE) | Up to approximately 3 weeks | An adverse event (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. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who experience a TEAE will be reported. |
| Number of Participants Who Discontinue Study Due to a TEAE | Up to approximately 3 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. An AE will be considered treatment-emergent if the onset date and time is at the time of or after the first study drug administration. The number of participants who discontinue study due to a TEAE will be reported. |
Countries
United States
Outcome results
None listed