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

NCT07314320 | Completed Phase 1 FDA Drug

• 1 other identifier: 323-201-00002
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Healthy Volunteers

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (19)

• 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

Study Arms (1)

[14C]-OPC-167832

EXPERIMENTAL

Participants receive a single dose of \[14C\]-OPC-167832, orally, on Day 1.

Drug: [14C]-OPC-167832

Interventions

[14C]-OPC-167832 DRUG

Oral suspension

[14C]-OPC-167832

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Otsuka Pharmaceutical Development & Commercialization, Inc.: lead

Study Sites (1)

Celerion, Inc

Lincoln, Nebraska, 68502, United States

Location

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 18, 2025
• First Posted: January 2, 2026
• Study Start: November 20, 2023
• Primary Completion: December 27, 2023
• Study Completion: December 27, 2023
• Last Updated: January 2, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• Access Criteria: Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/

Locations

US (1)