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| ID | Type | Description | Link |
|---|---|---|---|
| MK-5684-008 | Other Identifier | MSD | |
| 1010197 | Registry Identifier | IRAS |
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| Name | Class |
|---|---|
| Orion Corporation, Orion Pharma | INDUSTRY |
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This is a study of opevesostat in healthy adult male participants. The purpose of this study is to understand the absorption, distribution, metabolism, and elimination of opevesostat in humans, as well as its pharmacokinetics (PK), metabolic profile, and safety and tolerability.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [¹⁴C]Opevesostat | Experimental | On Day 1, participants receive a single dose of [¹⁴C]opevesostat as an oral solution. Participants then receive single doses of 5.0 mg prednisone and 0.05 mg fludrocortisone tablets 4 hours later as hormone replacement therapy. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [¹⁴C]Opevesostat | Drug | Oral solution |
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| Measure | Description | Time Frame |
|---|---|---|
| Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat | Urine samples will be collected at pre-specified timepoints and used to determine CumAeu. | Predose and at designated time points (up to 8 days) |
| Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat | Fecal samples will be collected at pre-specified timepoints and used to determine CumAef. | Predose and at designated time points (up to 8 days) |
| Cumulative percentage of total radioactivity excreted in urine (Cumfeu) after administration of single-dose [¹⁴C]Opevesostat | Urine samples will be collected at pre-specified timepoints and used to determine CumFeu. | Predose and at designated time points (up to 8 days) |
| Cumulative percentage of total radioactivity excreted in feces (Cumfef) after administration of single-dose [¹⁴C]Opevesostat | Fecal samples will be collected at pre-specified timepoints and used to determine Cumfef. | Predose and at designated time points (up to 8 days) |
| Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of opevesostat. | Predose and at designated time points (up to 8 days) |
| Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of opevesostat. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants with 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who experienced an AE will be reported. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Director | Merck Sharp & Dohme LLC | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Quotient Sciences ( Site 0001) | Nottingham | Nottinghamshire | NG11 6JS | United Kingdom |
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| Label | URL |
|---|---|
| Merck Clinical Trials Information | View source |
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| Prednisone | Drug | Tablet |
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| Fludrocortisone | Drug | Tablet |
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| Predose and at designated time points (up to 8 days) |
| Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax) | Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of opevesostat. | Predose and at designated time points (up to 8 days) |
| Plasma Opevesostat Pharmacokinetics: Time of maximum observed concentration (Tmax) | Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of opevesostat. | Predose and at designated time points (up to 8 days) |
| Plasma Opevesostat Pharmacokinetics: Terminal elimination half-life (t1/2) | Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of opevesostat. | Predose and at designated time points (up to 8 days) |
| Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of total radioactivity. | Predose and at designated time points (up to 8 days) |
| Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of total radioactivity. | Predose and at designated time points (up to 8 days) |
| Plasma Total Radioactivity Pharmacokinetics: Maximum observed concentration (Cmax) | Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of total radioactivity. | Predose and at designated time points (up to 8 days) |
| Plasma Total Radioactivity Pharmacokinetics: Time of maximum observed concentration (Tmax) | Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of total radioactivity. | Predose and at designated time points (up to 8 days) |
| Plasma Total Radioactivity Pharmacokinetics: Terminal elimination half-life (t1/2) | Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of total radioactivity. | Predose and at designated time points (up to 8 days) |
| Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity | Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry. | Predose and at designated time points (up to 8 days) |
| Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity | Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry. | Predose and at designated time points (up to 8 days) |
| Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity | Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry. | Predose and at designated time points (up to 8 days) |
| Up to approximately 8 days |
| Number of Participants who Discontinue from the Study 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. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study intervention. The number of participants who discontinue from the study due to an AE will be reported. | Up to approximately 8 days |
| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D005438 | Fludrocortisone |
| C034635 | fludrocortisone acetate |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006854 | Hydrocortisone |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
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