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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| [14C]-OPC-167832 | Experimental | Participants receive a single dose of [14C]-OPC-167832, orally, on Day 1. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| [14C]-OPC-167832 | Drug | Oral suspension |
|
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:
Body mass index (BMI) between 18 to 32 kilograms per square meter (kg/m^2) (inclusive).
In good health as determined by:
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:
Note: Other protocol-specified inclusion/exclusion criteria may apply.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Celerion, Inc | Lincoln | Nebraska | 68502 | United States |
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.
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.
Otsuka will share data on the Vivli data sharing platform: https://vivli.org/ourmember/Otsuka/
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 26, 2026 |
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| 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 |