Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT07455084 · ClinicalTrials.gov registry record · Phase 1

A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults

A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

Not yet
Registry status
Phase 1
Development phase
8
Enrollment target

NCT07455084: Clinical Trial Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NCT07455084 is a Phase 1 study that has not yet begun recruiting, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 8 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower). According to ClinicalTrials.gov, the official US trial registry.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT07455084, a Phase 1 study, has not yet begun recruiting, sponsored by Otsuka Pharmaceutical Development & Commercialization.

NOT YET RECRUITING
Registry status
Phase 1
Development phase
8 participants
Enrollment target

Study Summary

The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.

Interventions

  • DRUG 14C-SEP-380135

Trial Details

FieldValue
Enrollment Target 8 participants
Start Date 2026-03-20
Est. Completion 2026-05-03
Phase Phase 1

What is known before NCT07455084 opens enrollment

NCT07455084 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 8 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (87% lower).

The record links to 0 conditions, and to 1 intervention - of which 14C-SEP-380135 is the first listed.

NCT07455084 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT07455084 about?

NCT07455084 is a clinical study titled "A Study to Detect the Radioactivity of 14C-SEP-380135 in Urine and Feces in Healthy Male Adults". The purpose of the present trial is to obtain information on the absorption, distribution, metabolism, excretion and pharmacokinetics (PK) of 14C-SEP-380135 and its metabolites following a single oral dose.

What is the current status of trial NCT07455084?

This trial is currently not yet recruiting. It is a Phase 1 study. The enrollment target is 8 participants. The study started on 2026-03-20. Estimated completion is 2026-05-03.

What interventions are being tested in trial NCT07455084?

The interventions under investigation include: 14C-SEP-380135 (DRUG).

Who is sponsoring clinical trial NCT07455084?

This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT07455084's enrollment target sits among peer trials

8 1959th of 2000 higher than 29 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

Nationwide trials with similar profiles

Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.

Similar registry start date

  • NCT05962346 · started 2026-12 · NA

    Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia

  • NCT07125183 · started 2026-12 · Phase 2

    Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma

  • NCT07292298 · started 2026-11 · Phase 2

    Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates

  • NCT04263285 · started 2026-10 · NA

    Treatment of Depression Post-SCI

Source: ClinicalTrials.gov NCT07455084, the US trial registry maintained by the National Library of Medicine. NCT07455084 (small enrollment · none site footprint · not yet recruiting) retrieved and formatted by PlainTrial, see methodology.