A Study to Detect Radioactivity of [14C]-OPC‑167832 in Urine and Feces in Healthy Men

Sponsor ID
323-201-00002
Clinicaltrials.gov ID
NCT07314320
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
323-201-00002
Trial Details
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Age
18 - 55 Years
Therapeutic Area
  • Healthy Volunteers
    • Sex
    Male
    Trial Dates
    Nov 2023 - Dec 2023
    Healthy Volunteers
    Yes
    • Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m\^2) (inclusive).
    • In good health as determined by:
    • Medical history
    • Physical examination
    • ECG
    • Serum/urine biochemistry, hematology, and serology tests.
    • Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.
    • Agree to remain exclusively in the research unit for the defined period.
    • Agree to comply with the protocol restrictions and requirements.
    • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    • Male participants and their female partners who commit to remaining abstinent from trial screening through 90 days after the dose of investigational medicinal product (IMP) or utilizing 2 different approved methods of birth control from trial screening through 90 days after the dose of IMP.
    • Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP.
    • Clinically relevant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including distribution, metabolism, and excretion of drug.
    • History of drug and/or alcohol abuse within 2 years prior to screening.
    • History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.
    • Participants having taken OPC-167832 within 30 days prior to screening.
    • Participants having 5 half-lives or twice the duration of the biological effect, whichever is longer, of any IMP (inclusive of OPC-167832) within 30 days prior to screening.
    • Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.
    • Any participant who, in the opinion of the investigator, should not participate in the trial.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Study Summary

    The purpose of this study is to determine the relative amounts of radioactivity excreted in urine and feces following a single oral dose of \[14C\]-OPC-167832 in healthy male participants.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: [14C]-OPC-167832
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    8
    Additional Study Details

    Inclusion and Exclusion Criteria

    Inclusion Criteria

    • 1. Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m\^2) (inclusive).
    • 2. In good health as determined by:

    Exclusion Criteria

    • 1. Clinically relevant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including distribution, metabolism, and excretion of drug.
    • 2. History of drug and/or alcohol abuse within 2 years prior to screening.
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    • Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m\^2) (inclusive).
    • In good health as determined by:
    • Medical history
    • Physical examination
    • ECG
    • Serum/urine biochemistry, hematology, and serology tests.
    • Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.
    • Agree to remain exclusively in the research unit for the defined period.
    • Agree to comply with the protocol restrictions and requirements.
    • Ability to provide written, informed consent prior to initiation of any trial-related procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
    • Male participants and their female partners who commit to remaining abstinent from trial screening through 90 days after the dose of investigational medicinal product (IMP) or utilizing 2 different approved methods of birth control from trial screening through 90 days after the dose of IMP.
    • Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP.
    Exclusion Criteria:
    • Clinically relevant abnormality in past medical history, or at the screening physical examination, that in the investigator's or sponsor's opinion may place the participant at risk or interfere with outcome variables including distribution, metabolism, and excretion of drug.
    • History of drug and/or alcohol abuse within 2 years prior to screening.
    • History of or current hepatitis or carriers of hepatitis B surface antigen (HBsAg) and/or anti-hepatitis C virus (HCV), or human immunodeficiency virus (HIV) antibodies.
    • History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.
    • Participants having taken OPC-167832 within 30 days prior to screening.
    • Participants having 5 half-lives or twice the duration of the biological effect, whichever is longer, of any IMP (inclusive of OPC-167832) within 30 days prior to screening.
    • Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.
    • Any participant who, in the opinion of the investigator, should not participate in the trial.
    • Note: Other protocol-specified inclusion/exclusion criteria may apply.

    Locations

    Location
    Status
    Location
    Celerion, Inc
    Lincoln, Nebraska, United States, 68502
    Status
    N/A

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