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NCT07549581 · ClinicalTrials.gov registry record · Phase 1
A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 43
- Enrollment target
NCT07549581 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 43 participants.
The verdict
NCT07549581, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 43 participants
- Enrollment target
Study Summary
The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive disorder (MDD).
Interventions
- DRUG Placebo
- DRUG SEP-380135
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 43 participants |
| Start Date | 2024-11-07 |
| Est. Completion | 2025-09-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07549581
The ClinicalTrials.gov registry entry for NCT07549581 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 43 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07549581 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07549581 about?
NCT07549581 is a clinical study titled "A Study of SEP-380135 in Adults With Schizophrenia or Major Depressive Episode". The purpose of this study is to assess the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple dose oral administration of SEP-380135 in participants with schizophrenia or with a major depressive episode associated with bipolar I or II disorder or major depressive diso...
What is the current status of trial NCT07549581?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 43 participants. The study started on 2024-11-07. Estimated completion is 2025-09-12.
What interventions are being tested in trial NCT07549581?
The interventions under investigation include: Placebo (DRUG), SEP-380135 (DRUG).
Who is sponsoring clinical trial NCT07549581?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
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