Researchers have designed a study medicine called opevesostat as a new way to treat prostate cancer. The purpose of this study is to learn what happens to opevesostat in a person's body over time (a pharmacokinetic or PK study). Researchers will compare what happens to opevesostat in the body when it is given with and without another medicine called carbamazepine.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Enrollment
14
Administered via oral tablet per dosing regimen.
Administered at a dose of 5 mg or 10 mg dependent on HRT dosing regimen via oral tablets.
Administered at a dose of 0.05 mg or 0.1 mg dependent on 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 opevesostat in plasma
AUC0-inf of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat in plasma
AUC0-last of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Area under the concentration versus time curve from 0 to hour 24 (AUC0-24) of opevesostat in plasma
AUC0-24 of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 24 hours post-dose
Maximum concentration (Cmax) of opevesostat in plasma
Cmax of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Time to Maximum concentration (Tmax) of opevesostat in plasma
Tmax of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Apparent terminal half-life (t1/2) of opevesostat in plasma
t1/2 of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
Apparent Clearance (CL/F) of opevesostat in plasma
CL/F of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 hours post-dose
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Administered at a dose of 100 mg, 200 mg, or 300 mg BID dependent on dosing regimen via oral capsule (extended-release).
Apparent volume of distribution during terminal phase (Vz/F) of opevesostat in plasma
Vz/F of opevesostat in plasma will be determined.
Time frame: Predose, and at designated timepoints up to 96 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. The number of participants who experience an AE will be determined.
Time frame: Up to approximately 49 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. The number of participants who discontinue from the study due to an AE will be determined.
Time frame: Up to approximately 49 days