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

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

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.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Drug: [14C]-OPC-167832

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Nebraska
    • Lincoln, Nebraska, United States, 68502
      • Celerion, Inc

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

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:

   1. Medical history
   2. Physical examination
   3. ECG
   4. Serum/urine biochemistry, hematology, and serology tests.
3. Experience regular bowel movements (i.e., at least 1 every day) for 30 days prior to Day -1.
4. Agree to remain exclusively in the research unit for the defined period.
5. Agree to comply with the protocol restrictions and requirements.
6. 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.
7. 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.
8. Commit to refraining from sperm donation from the screening visit through 90 days after the dose of IMP.

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.
3. 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.
4. History of any significant drug allergy or known or suspected hypersensitivity, to any component of the IMP.
5. Participants having taken OPC-167832 within 30 days prior to screening.
6. 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.
7. Participation in a clinical trial involving administration of 14C-labelled compound(s) within the last 12 months prior to screening.
8. 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]-OPC-167832; Participants receive a single dose of [14C]-OPC-167832, orally, on Day 1.	Drug: [14C]-OPC-167832; Oral suspension

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u)	Up to Day 31
Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Feces (Ae,f)	Up to Day 31
Percentage of OPC-167832 Dose Excreted in Urine (%fe,u)	Up to Day 31
Percentage of OPC-167832 Dose Excreted in Feces (%fe,f)	Up to Day 31

Secondary Outcome Measures

Outcome Measure	Time Frame
Maximum (peak) Concentration (Cmax) of Total Radioactivity in Plasma and Whole Blood	Up to Day 31
Time to Maximum (Peak) Concentration (Tmax) of Total Radioactivity in Plasma and Whole Blood	Up to Day 31
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	Up to Day 31
Area Under the Concentration-Time Curve From Time Zero to infinity (AUCinfinity) of Total Radioactivity in Plasma and Whole Blood	Up to Day 31
Terminal-phase Elimination Half-life (t1/2,z) of Total Radioactivity in Plasma and Whole Blood	Up to Day 31
Hemocrit Blood to Plasma Concentration Adjusted Ratio	Up to Day 31
Percentage of Metabolite in Plasma With an AUC > 10% of the AUC of Plasma Radioactivity Based on Radiometric Profiling	Up to Day 31
Cmax of OPC-167832	Up to Day 31
Tmax of OPC-167832	Up to Day 31
AUCt of OPC-167832	Up to Day 31
AUCinfinity of OPC-167832	Up to Day 31
t1/2,z of OPC-167832	Up to Day 31
Apparent Clearance (CL/F) of Drug from Plasma Following Extravascular Administration of OPC-167832	Up to Day 31
Percent Radioactivity Excreted in Urine and Feces as Parent and Identified Metabolites From Profiling data	Up to Day 31
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)	Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Clinical Laboratory Tests	Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Vital Signs	Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Physical Examinations	Up to Day 31
Number of Participants With Potentially Clinically Relevant Changes in Electrocardiogram (ECG) Parameters	Up to Day 31

Collaborators and Investigators

• Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): November 20, 2023
• Primary Completion (Actual): December 27, 2023
• Study Completion (Actual): December 27, 2023

Study Registration Dates

• First Submitted: December 18, 2025
• First Submitted That Met QC Criteria: December 18, 2025
• First Posted (Estimated): January 2, 2026

Study Record Updates

• Last Update Posted (Estimated): January 2, 2026
• Last Update Submitted That Met QC Criteria: December 18, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 323-201-00002

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Anonymized individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal. Small studies with less than 25 participants are excluded from data sharing.
• IPD Sharing Time Frame: Data will be available after marketing approval in global markets, or beginning 1-3 years following article publication. There is no end date to the availability of the data.
• IPD Sharing Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No