How [14C]-JNT‑517 is Absorbed, Broken Down, and Removed From the Body After a Single Oral Dose in Healthy Male Participants

Sponsor ID
359-201-00003
Clinicaltrials.gov ID
NCT07573449
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
359-201-00003
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Male
    Trial Dates
    Jan 2024 - Jan 2025
    Healthy Volunteers
    Yes
    • Inclusion Criteria
    • Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
    • In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable).
    • History of a minimum of 1 bowel movement per day.
    • Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.
    • Exclusion Criteria
    • Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
    • Alcohol consumption of \>14 units per week.
    • A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
    • Participants having taken an investigational drug within 30 days prior to screening.
    • Participants who have previously been dosed in \>2 radiolabeled drug studies in the last 12 months.
    • Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal).
    • Previous exposure to JNT-517.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Study Summary

    The purpose of this study is to determine the absorption, metabolism and excretion of \[14C\]-JNT-517 and to characterize and determine the metabolites present in plasma, urine, and feces in healthy male participants following a single oral administration.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: [14C]-JNT-517
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    8
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Inclusion Criteria
    • 1. Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.

    Exclusion Criteria

    Inclusion and Exclusion Criteria
    • Inclusion Criteria
    • Body mass index (BMI) between 18.0 to 32.0 kilograms per square meter (kg/m\^2), inclusive.
    • In good health at screening as determined by: a) Medical history, b) Physical examination, c) ECG, d) Clinical laboratory evaluations (congenital nonhemolytic hyperbilirubinemia \[e.g. suspicion of Gilbert's syndrome based on total and direct bilirubin\] is not acceptable).
    • History of a minimum of 1 bowel movement per day.
    • Able to comprehend and are willing to sign the Informed consent form (ICF) and abide by the study restrictions.
    • Exclusion Criteria
    • Use or intend to use any medications/products known to alter drug absorption, metabolism and excretion processes, including St. John's wort, within 30 days prior to dosing, considered to potentially impact participant safety or the objectives of the study, as determined by the investigator or designee.
    • Alcohol consumption of \>14 units per week.
    • A Positive urine drug screen at screening or positive alcohol test result or positive urine drug screen at check-in.
    • Participants having taken an investigational drug within 30 days prior to screening.
    • Participants who have previously been dosed in \>2 radiolabeled drug studies in the last 12 months.
    • Participants with exposure to significant diagnostic or therapeutic radiation (e.g. serial X-ray, computed tomography scan, barium meal).
    • Previous exposure to JNT-517.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Locations

    Location
    Status
    Location
    Fortrea Clinical Research Unit Inc.
    Madison, Wisconsin, United States, 53704
    Status
    N/A

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