Healthy
Conditions
Brief summary
The purpose of this study is to learn what happens to MK-8591A in a person's body over time. Researchers will compare what happens to MK-8591A in the body when it is given with and without food.
Interventions
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
Inclusion Criteria include, but are not limited to: * Has a body mass index (BMI) ≥ 18.0 and ≤ 32.0 kg/m\^2 * Is medically healthy with no clinically significant medical history, physical examination, clinical laboratory profiles, vital signs, and electrocardiograms (ECGs)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cmax of ISL | At designated time points up to ~30 days | Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of ISL. |
| AUC0-inf of ISL | At designated time points up to ~30 days | AUC0-inf is a measure of plasma drug concentration and time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of ISL. |
| AUC0-last of ISL | At designated time points up to ~30 days | AUC0-last is defined as the area under the concentration-time curve from time zero to time of last measurable concentration of ISL. Blood will be collected at designated time points to determine the AUC0-last of ISL. |
| Area under the curve from time 0-infinity (AUC0-inf) of DOR | At designated time points up to ~30 days | AUC0-inf is a measure of plasma drug concentration from time 0 to infinity and is estimated as the area under the plot of plasma concentration against time 0 to infinity after drug administration. Blood samples collected at designated time points will be used to determine the AUC0-inf of DOR. |
| Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine | At designated time points up to ~30 days | AUC0-last is defined as the area under the concentration-time curve from time 0 to time of last measurable concentration of DOR. Blood will be collected at designated time points to determine the AUC0-last of DOR. |
| Maximum plasma concentration (Cmax) of doravine | At designated time points up to ~30 days | Cmax is the maximum concentration of the drug observed in plasma. Blood samples collected at designated time points will be used to determine Cmax of DOR. |
| Plasma concentration at 24 hours postdose (C24) of DOR | At designated time points up to ~24 hours postdose | C24 is the concentration at 24 hours postdose of the drug observed in plasma. Blood samples collected at 24 postdose will be used to determine C24 of DOR. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinued study intervention due to an AE | Up to ~30 days | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants who discontinue study intervention due to an AE will be reported. |
| Number of participants who experienced an adverse event (AE) | Up to ~44 days | An AE is defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug related. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. The number of participants with an adverse event will be reported. |
Countries
United States
Outcome results
None listed