Researchers have designed a study medicine called MK-5684 as a new way to treat prostate cancer. The purpose of this study is to learn what happens to MK-5684 in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to MK-5684 in the body when it is given with and without another medicine called diltiazem.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administered via oral tablet per dosing regimen.
Administered at a dose of 2.5 mg or 5 mg dependent on HRT dosing regimen via oral tablets.
Administered at a dose of 0.05 mg per HRT dosing regimen via oral tablets.
Celerion ( Site 0001)
Tempe, Arizona, United States
Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of MK-5684 in plasma
AUC0-inf of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of MK-5684 in plasma
AUC0-last of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Area under the concentration versus time curve from 0 to Hour 24 (AUC0-24) of MK-5684 in plasma
AUC0-24 of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 24 hours post-dose
Maximum concentration (Cmax) of MK-5684 in plasma
Cmax of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Time to Maximum concentration (Tmax) of MK-5684 in plasma
Tmax of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Apparent terminal half-life (t1/2) of MK-5684 in plasma
t1/2 of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Apparent Clearance (CL/F) of MK-5684 in plasma
CL/F of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
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Administered at a dose of 240 mg per dosing regimen via oral capsule (extended-release).
Apparent volume of distribution during terminal phase (Vz/F) of MK-5684 in plasma
Vz/F of MK-5684 in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 120 hours post-dose
Number of participants who experience one or more adverse events (AEs)
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.
Time frame: Up to approximately 39 days
Number of participants who discontinue study intervention due to an AE
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.
Time frame: Up to approximately 39 days