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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5684-017 | Other Identifier | MSD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Opevesostat Period 1 | Experimental | On Day 1, a single dose of opevesostat will be administered under fed conditions. A single dose of steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions approximately 4.5 hours after opevesostat dosing. |
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| Opevesostat Period 2 | Experimental | There will be a washout of at least 5 days between opevesostat dosing in Period 1 and the first itraconazole dosing in Period 2. In Period 2, itraconazole will be administered once daily (QD) for 9 consecutive days with a single dose of opevesostat coadministered on Day 4 under fed conditions. Steroid replacement (prednisone and fludrocortisone) will be administered under fed conditions QD on Days 4 through 6, approximately 4.5 hours after opevesostat and/or itraconazole dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opevesostat | Drug | Administered via oral film-coated tablet |
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| Measure | Description | Time Frame |
|---|---|---|
| Area under the concentration versus time curve from 0 to infinity after single dosing (AUC0-inf) of opevesostat | Blood samples will be collected to determine the AUC0-inf of opevesostat. | Predose, and at designated timepoints up to 144 hours post-dose |
| Area under the concentration versus time curve from 0 to last quantifiable sample (AUC0-last) of opevesostat | Blood samples will be collected to determine the AUC0-last of opevesostat. | Predose, and at designated timepoints up to 144 hours post-dose |
| Maximum concentration (Cmax) of opevesostat | Blood samples will be collected to determine the Cmax of opevesostat. | Predose, and at designated timepoints up to 144 hours post-dose |
| Time to Maximum concentration (Tmax) of opevesostat | Blood samples will be collected to determine the Tmax of opevesostat. | Predose, and at designated timepoints up to 144 hours post-dose |
| Apparent terminal half-life (t1/2) of opevesostat | Blood samples will be collected to determine the t1/2 of opevesostat. | Predose, and at designated timepoints up to 144 hours post-dose |
| Apparent Clearance (CL/F) of opevesostat | Blood samples will be collected to determine the CL/F of opevesostat. | Predose, and at designated timepoints up to 144 hours post-dose |
| Apparent volume of distribution during terminal phase (Vz/F) of opevesostat |
| Measure | Description | Time Frame |
|---|---|---|
| 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 reported. | Up to approximately 28 days |
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Inclusion Criteria:
The main inclusion criteria include but are not limited to the following:
Exclusion Criteria:
The main exclusion criteria include but are not limited to the following:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc. ( Site 0001) | Lincoln | Nebraska | 68502 | United States |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C034635 | fludrocortisone acetate |
| D017964 | Itraconazole |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisone | Drug | Administered via oral tablet |
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| Fludrocortisone acetate | Drug | Administered via oral tablet |
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| Itraconazole | Drug | Administered via oral capsule |
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Blood samples will be collected to determine the Vz/F of opevesostat. |
| Predose, and at designated timepoints up to 144 hours post-dose |
| 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 study intervention due to an AE will be reported. | Up to approximately 28 days |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D010879 | Piperazines |