A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)
NCT Number: NCT06566989
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: PHASE1
Conditions: Metastatic Prostate Cancer
Interventions: DRUG: [¹⁴C]Opevesostat|DRUG: Prednisone|DRUG: Fludrocortisone
Sponsor: Merck Sharp & Dohme LLC
Collaborators: Orion Corporation, Orion Pharma
Sex: MALE
Age: ADULT
Enrollment: 8
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-09-20
Completion Date: 2024-10-13

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.

Primary Outcome Measures: 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., 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)
Secondary Outcome Measures: 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., 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