AzTrials
AzTrials

Healthy VolunteersPhase 1NCT07314320

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

A Phase 1 study testing [14C]-OPC-167832 in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 to 55 years, men onlyHealthy volunteers can take part
Conditions the study is for
Healthy Volunteers
What is being tested?
[14C]-OPC-167832
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
8 participants
Where
1 siteUnited States
Study dates
20 Nov 2023to 27 Dec 2023
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • Men only
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • 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.
Show all 12Show fewer
  • 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.

Who cannot join

  • 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.
Show all 9Show fewer
  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Celerion, Inc

    Lincoln, Nebraska, 68502

Other trials in United States

About this study

Official 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

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.

Being tested
[14C]-OPC-167832

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • [14C]-OPC-167832Drug

    Oral suspension

Study groups in NCT07314320
Study groupRoleWhat they receive
[14C]-OPC-167832ExperimentalParticipants receive a single dose of [14C]-OPC-167832, orally, on Day 1.
Receives: Drug: [14C]-OPC-167832

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

Secondary outcomes (19)

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

    Measured: Up to Day 31

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

    Measured: 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

    Measured: 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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

  6. Hemocrit Blood to Plasma Concentration Adjusted Ratio

    Measured: Up to Day 31

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

    Measured: Up to Day 31

  8. Cmax of OPC-167832

    Measured: Up to Day 31

  9. Tmax of OPC-167832

    Measured: Up to Day 31

  10. AUCt of OPC-167832

    Measured: Up to Day 31

  11. AUCinfinity of OPC-167832

    Measured: Up to Day 31

  12. t1/2,z of OPC-167832

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

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

    Measured: Up to Day 31

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Jan 2026
  2. Study start20 Nov 2023
  3. Primary completion27 Dec 2023
  4. Study completion27 Dec 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
8 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07314320
Sponsor's protocol ID
323-201-00002
Status last verified
Dec 2025
First submitted
18 Dec 2025
Last updated
2 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing [14C]-OPC-167832 in people with Healthy Volunteers, run by Otsuka Pharmaceutical Development & Commercialization, Inc. at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 12 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Cumulative Amount (Microgram Equivalents) of OPC-167832 Excreted in Urine (Ae,u) (time frame: Up to Day 31). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07314320.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in