Healthy
Conditions
Brief summary
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 itraconazole.
Interventions
DRUGOpevesostat
Administered via oral film-coated tablet
DRUGPrednisone
Administered via oral tablet
Administered via oral tablet
DRUGItraconazole
Administered via oral capsule
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
19 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Has a body mass index ≥18.0 and ≤32.0 kg/m\^2 * Is medically healthy with no clinically significant medical history
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the AUC0-inf of opevesostat. |
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the AUC0-last of opevesostat. |
| Maximum concentration (Cmax) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the Cmax of opevesostat. |
| Time to Maximum concentration (Tmax) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the Tmax of opevesostat. |
| Apparent terminal half-life (t1/2) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the t1/2 of opevesostat. |
| Apparent Clearance (CL/F) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the CL/F of opevesostat. |
| Apparent volume of distribution during terminal phase (Vz/F) of opevesostat | Predose, and at designated timepoints up to 144 hours post-dose | Blood samples will be collected to determine the Vz/F of opevesostat. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who experience one or more adverse events (AEs) | Up to approximately 28 days | 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 reported. |
| Number of participants who discontinue study intervention due to an AE | Up to approximately 28 days | 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 study intervention due to an AE will be reported. |
Countries
United States
Contacts
CONTACTToll Free Number
STUDY_DIRECTORMedical Director
Merck Sharp & Dohme LLC
Outcome results
None listed