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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
24
Celerion (Site 0001)
Lincoln, Nebraska, United States
Area under the curve from time 0-infinity (AUC0-inf) of DOR
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.
Time frame: At designated time points up to ~30 days
Area under the curve from time 0 to last measurable concentration (AUC0-last) of Doravine
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.
Time frame: At designated time points up to ~30 days
Maximum plasma concentration (Cmax) of doravine
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.
Time frame: At designated time points up to ~30 days
Plasma concentration at 24 hours postdose (C24) of DOR
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.
Time frame: At designated time points up to ~24 hours postdose
AUC0-inf of ISL
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.
Time frame: At designated time points up to ~30 days
AUC0-last of ISL
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.
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Time frame: At designated time points up to ~30 days
Cmax of ISL
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.
Time frame: At designated time points up to ~30 days
Number of participants who experienced an adverse event (AE)
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.
Time frame: Up to ~44 days
Number of participants who discontinued study intervention due to an AE
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.
Time frame: Up to ~30 days