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 carbamazepine.
Interventions
DRUGOpevesostat
Administered via oral tablet per dosing regimen.
DRUGPrednisone
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.
DRUGCarbamazepine
Administered at a dose of 100 mg, 200 mg, or 300 mg BID dependent on dosing regimen via oral capsule (extended-release).
Sponsors
Merck Sharp & Dohme LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
The main inclusion criteria include but are not limited to the following: * Continuous non-smoker who has not used nicotine- and tobacco-containing products for at least 3 months prior to the first dosing based on participant self-reporting * Body mass index (BMI) ≥18.0 and ≤32.0 kg/m\^2 * Able to swallow multiple tablets
Exclusion criteria
The main
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Apparent volume of distribution during terminal phase (Vz/F) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | Vz/F of opevesostat in plasma will be determined. |
| Apparent terminal half-life (t1/2) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | t1/2 of opevesostat in plasma will be determined. |
| Apparent Clearance (CL/F) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | CL/F of opevesostat in plasma will be determined. |
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | AUC0-inf of opevesostat in plasma will be determined. |
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | AUC0-last of opevesostat in plasma will be determined. |
| Area under the concentration versus time curve from 0 to hour 24 (AUC0-24) of opevesostat in plasma | Predose, and at designated timepoints up to 24 hours post-dose | AUC0-24 of opevesostat in plasma will be determined. |
| Maximum concentration (Cmax) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | Cmax of opevesostat in plasma will be determined. |
| Time to Maximum concentration (Tmax) of opevesostat in plasma | Predose, and at designated timepoints up to 96 hours post-dose | Tmax of opevesostat in plasma will be determined. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of participants who discontinue study intervention due to an AE | Up to approximately 49 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 from the study due to an AE will be determined. |
| Number of participants who experience one or more adverse events (AEs) | Up to approximately 49 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 determined. |
Countries
United States
Outcome results
None listed