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Completed

NCT Number: NCT07314320

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

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.

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Key information

Conditions

Age range

18 year–55 year

Sex eligibility

Male

Study type

Interventional

Phase

Phase 1

Primary location

Celerion, Inc

Lincoln, Nebraska, 68502, United States

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

[14C]-OPC-167832

Drug

Oral suspension

Primary outcomes

  1. Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)

    Time frame: Up to Day 31

  2. Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)

    Time frame: Up to Day 31

  3. Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)

    Time frame: Up to Day 31

  4. Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)

    Time frame: Up to Day 31

Secondary outcomes

  1. Maximum (peak) Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 31

  2. Time to Maximum (Peak) Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 31

  3. Area Under the Concentration-Time Curve From Time Zero to the Time of the Last Observable Concentration (AUCt) of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 31

  4. Area Under the Concentration-Time Curve From Time Zero to infinity (AUCinfinity) of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 31

  5. Terminal-phase Elimination Half-life (t1/2,z) of Total Radioactivity in Plasma and Whole Blood

    Time frame: Up to Day 31

  6. Hemocrit Blood to Plasma Concentration Adjusted Ratio

    Time frame: Up to Day 31

  7. Percentage of Metabolite in Plasma With an AUC > 10% of the AUC of Plasma Radioactivity Based on Radiometric Profiling

    Time frame: Up to Day 31

  8. Cmax of OPC-167832

    Time frame: Up to Day 31

  9. Tmax of OPC-167832

    Time frame: Up to Day 31

  10. AUCt of OPC-167832

    Time frame: Up to Day 31

  11. AUCinfinity of OPC-167832

    Time frame: Up to Day 31

  12. t1/2,z of OPC-167832

    Time frame: Up to Day 31

  13. Apparent Clearance (CL/F) of Drug from Plasma Following Extravascular Administration of OPC-167832

    Time frame: Up to Day 31

  14. Percent Radioactivity Excreted in Urine and Feces as Parent and Identified Metabolites From Profiling data

    Time frame: Up to Day 31

  15. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    Time frame: Up to Day 31

  16. Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests

    Time frame: Up to Day 31

  17. Number of Participants With Potentially Clinically Relevant Changes in Vital Signs

    Time frame: Up to Day 31

  18. Number of Participants With Potentially Clinically Relevant Changes in Physical Examinations

    Time frame: Up to Day 31

  19. Number of Participants With Potentially Clinically Relevant Changes in Electrocardiogram (ECG) Parameters

    Time frame: Up to Day 31

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Development & Commercialization, Inc.

Industry

Registry information

Official study title

A Phase 1, Open-Label, Single-Dose Trial to Evaluate the Mass Balance and Pharmacokinetics of [14C]-OPC-167832 Administered Orally in Healthy Male Subjects

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jan 2, 2026
Registry last updated
Jan 2, 2026

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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