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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.
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
| Field | Value |
|---|---|
| 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.
Learn More About Clinical Trials
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
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