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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5684-009 | 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 [PK] study). Researchers will compare what happens to opevesostat in the body when it is given to healthy participants and participants with moderate hepatic (liver) impairment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Moderate Hepatic Impairment | Experimental | On Day 1, participants with moderate hepatic impairment will receive a single oral dose of opevesostat under fasting conditions and a single dose of hormone replacement therapy (HRT) (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. Participants with moderate hepatic impairment will receive another dose of HRT on Day 2. |
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| Healthy | Experimental | On Day 1, healthy participants will receive a single oral dose of opevesostat under fasting conditions and a single dose of HRT (prednisone and fludrocortisone acetate) under fed conditions approximately 4.5 hours after opevesostat dosing. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Opevesostat | Drug | Oral film-coated tablet |
|
| Measure | Description | Time Frame |
|---|---|---|
| Area Under the Concentration Versus Time Curve from 0 to Infinity (AUC0-inf) of Opevesestat | Plasma samples will be collected to determine the AUC0-inf of opevesostat. | At designated timepoints (up to approximately 96 hours post-dose) |
| Area Under the Concentration Versus Time Curve from 0 to the Last Quantifiable Sample (AUC0-last) of Opevesestat | Plasma samples will be collected to determine the AUC0-last of opevesostat. | At designated timepoints (up to approximately 96 hours post-dose) |
| Area Under the Concentration Versus Time Curve from 0 to 24 hours (AUC0-24) of Opevesestat | Plasma samples will be collected to determine the AUC0-24 of opevesostat. | At designated timepoints (up to approximately 24 hours post-dose) |
| Maximum Observed Concentration (Cmax) of Opevesestat | Plasma samples will be collected to determine the Cmax of opevesostat. | At designated timepoints (up to approximately 96 hours post-dose) |
| Time to Maximum Concentration (Tmax) of Opevesestat | Plasma samples will be collected to determine the Tmax of opevesostat. | At designated timepoints (up to approximately 96 hours post-dose) |
| Apparent Terminal Half-life (t1/2) of Opevesestat | Plasma samples will be collected to determine the t1/2 of opevesostat. | At designated timepoints (up to approximately 96 hours post-dose) |
| Apparent Clearance (CL/F) of Opevesestat |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Who Experience One or More Adverse Events (AEs) | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to approximately 2 weeks |
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The main inclusion criteria include but are not limited to the following:
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 |
|---|---|---|---|---|---|---|
| Clinical Pharmacology of Miami ( Site 0002) | Miami | Florida | 33172 | United States | ||
| Texas Liver Institute ( Site 0001) |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| C034635 | fludrocortisone acetate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Prednisone | Drug | Oral tablet |
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| Fludrocortisone acetate | Drug | Oral tablet |
|
Plasma samples will be collected to determine the CL/F of opevesostat. |
| At designated timepoints (up to approximately 96 hours post-dose) |
| Apparent Volume of Distribution During Terminal Phase (Vz/F) of Opevesestat | Plasma samples will be collected to determine the Vz/F of opevesostat. | At designated timepoints (up to approximately 96 hours post-dose) |
| Number of Participants Who Discontinue Study Due to an AE | An AE is defined as any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. | Up to approximately 2 weeks |
| San Antonio |
| Texas |
| 78215 |
| United States |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |