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Completed

NCT Number: NCT06566989

A Study of the Absorption, Distribution, Metabolism, and Elimination of Opevesostat (MK-5684) in Healthy Adult Male Participants (MK-5684-008)

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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Key information

Conditions

Metastatic Prostate Cancer Genital Diseases Genital Diseases, Male Genital Neoplasms, Male Male Urogenital Diseases Neoplasms Neoplasms by Site Prostatic Diseases Prostatic Neoplasms Urogenital Diseases Urogenital Neoplasms

Age range

30 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Quotient Sciences ( Site 0001)

Nottingham, Nottinghamshire, NG11 6JS, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

[¹⁴C]Opevesostat

Drug

Oral solution

Other names: MK-5684

Prednisone

Drug

Tablet

Other names: RAYOS®, STERAPRED®, DELTASONE®

fludrocortisone

Drug

Tablet

Other names: FLORINEF®

Primary outcomes

  1. Cumulative amount of total radioactivity excreted in urine (CumAeu) after administration of single-dose [¹⁴C]Opevesostat

    Time frame: Predose and at designated time points (up to 8 days)

    Urine samples will be collected at pre-specified timepoints and used to determine CumAeu.

  2. Cumulative amount of total radioactivity excreted in feces (CumAef) after administration of single-dose [¹⁴C]Opevesostat

    Time frame: Predose and at designated time points (up to 8 days)

    Fecal samples will be collected at pre-specified timepoints and used to determine CumAef.

  3. Cumulative percentage of total radioactivity excreted in urine (Cumfeu) after administration of single-dose [¹⁴C]Opevesostat

    Time frame: Predose and at designated time points (up to 8 days)

    Urine samples will be collected at pre-specified timepoints and used to determine CumFeu.

  4. Cumulative percentage of total radioactivity excreted in feces (Cumfef) after administration of single-dose [¹⁴C]Opevesostat

    Time frame: Predose and at designated time points (up to 8 days)

    Fecal samples will be collected at pre-specified timepoints and used to determine Cumfef.

  5. Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)

    Time frame: 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.

  6. Plasma Opevesostat Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)

    Time frame: 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.

  7. Plasma Opevesostat Pharmacokinetics: Maximum observed concentration (Cmax)

    Time frame: 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.

  8. Plasma Opevesostat Pharmacokinetics: Time of maximum observed concentration (Tmax)

    Time frame: 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.

  9. Plasma Opevesostat Pharmacokinetics: Terminal elimination half-life (t1/2)

    Time frame: 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.

  10. Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to the time of last measurable concentration (AUC0-t)

    Time frame: 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.

  11. Plasma Total Radioactivity Pharmacokinetics: Area under the curve from time 0 to extrapolated infinity (AUC0-inf)

    Time frame: 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.

  12. Plasma Total Radioactivity Pharmacokinetics: Maximum observed concentration (Cmax)

    Time frame: 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.

  13. Plasma Total Radioactivity Pharmacokinetics: Time of maximum observed concentration (Tmax)

    Time frame: 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.

  14. Plasma Total Radioactivity Pharmacokinetics: Terminal elimination half-life (t1/2)

    Time frame: 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.

  15. Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity

    Time frame: 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.

  16. Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity

    Time frame: 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.

  17. Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity

    Time frame: 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.

Secondary outcomes

  1. Number of Participants with One or More Adverse Events (AEs)

    Time frame: 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.

  2. Number of Participants who Discontinue from the Study Due to an AE

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Collaborators

  • Orion Corporation, Orion Pharma

Registry information

Official study title

An Open-label Phase 1 Study to Evaluate Metabolism, Excretion, and Mass Balance of [¹⁴C]MK-5684 in Healthy Male Participants

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Aug 22, 2024
Registry last updated
Oct 23, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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