Metastatic Prostate Cancer
Conditions
Brief summary
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.
Interventions
DRUG[¹⁴C]Opevesostat
Oral solution
DRUGPrednisone
Tablet
DRUGFludrocortisone
Tablet
Sponsors
Orion Corporation, Orion Pharma
Merck Sharp & Dohme LLC
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
30 Years to 55 Years
Healthy volunteers
Yes
Inclusion criteria
* Is a healthy male according to the assessment of the investigator * Has a body mass index of 18.0 to 32.0 kg/m2 * Has regular bowel movements (i.e., average stool production of ≥1 and ≤3 stools per day)
Exclusion criteria
* Has the presence or history of clinically significant allergy requiring treatment * Has a history of adrenal insufficiency * Has veins not suitable for multiple venipunctures/cannulation * Has previously taken part in more than 3 radiolabeled drug studies in the last 12 months * Has donated blood or plasma within the previous 3 months or lost greater than 400 mL of blood
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity | Predose and at designated time points (up to 8 days) | 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. |
| Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity | Predose and at designated time points (up to 8 days) | 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. |
| Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity | Predose and at designated time points (up to 8 days) | 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. |
| Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat | Predose and at designated time points (up to 8 days) | Urine samples will be collected at pre-specified timepoints and used to determine CumAeu. |
| Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat | Predose and at designated time points (up to 8 days) | Fecal samples will be collected at pre-specified timepoints and used to determine CumAef. |
| Cumulative percentage of total radioactivity excreted in urine (Cumfeu) after administration of single-dose [¹⁴C]Opevesostat | Predose and at designated time points (up to 8 days) | Urine samples will be collected at pre-specified timepoints and used to determine CumFeu. |
| Cumulative percentage of total radioactivity excreted in feces (Cumfef) after administration of single-dose [¹⁴C]Opevesostat | Predose and at designated time points (up to 8 days) | Fecal samples will be collected at pre-specified timepoints and used to determine Cumfef. |
| Plasma Opevesostat Pharmacokinetics: Terminal elimination half-life (t1/2) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of opevesostat. |
| Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of total radioactivity. |
| Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-t of opevesostat. |
| Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of opevesostat. |
| Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of opevesostat. |
| Plasma Opevesostat Pharmacokinetics: Time of maximum observed concentration (Tmax) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of opevesostat. |
| Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine AUC0-inf of total radioactivity. |
| Plasma Total Radioactivity Pharmacokinetics: Maximum observed concentration (Cmax) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of total radioactivity. |
| Plasma Total Radioactivity Pharmacokinetics: Time of maximum observed concentration (Tmax) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine Tmax of total radioactivity. |
| Plasma Total Radioactivity Pharmacokinetics: Terminal elimination half-life (t1/2) | Predose and at designated time points (up to 8 days) | Plasma samples will be collected at pre-specified timepoints and used to determine t1/2 of total radioactivity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants who Discontinue from the Study Due to an AE | Up to approximately 8 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. 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. |
| Number of Participants with One or More Adverse Events (AEs) | Up to approximately 8 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. 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. |
Countries
United Kingdom
Outcome results
None listed