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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Quotient Sciences ( Site 0001)
Nottingham, Nottinghamshire, United Kingdom
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated time points (up to 8 days)
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Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax)
Plasma samples will be collected at pre-specified timepoints and used to determine Cmax of opevesostat.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Predose and at designated time points (up to 8 days)
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.
Time frame: 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.
Time frame: Up to approximately 8 days