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NCT07305779 · ClinicalTrials.gov registry record · Phase 1
A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women
A Phase 1 study of Schizophrenia, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
- 1
- Study location
NCT07305779 is a Phase 1 study of Schizophrenia that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 12 participants, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state.
The verdict
NCT07305779, a Phase 1 study of Schizophrenia, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.
Conditions Studied
Interventions
- DRUG SEP-380135
- DRUG Quinidine Gluconate
Study Locations (1)
Kansas
- Dr. Vince Clinical Research - Overland Park
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2025-03-07 |
| Est. Completion | 2025-05-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07305779
The ClinicalTrials.gov registry entry for NCT07305779 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 12 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 219-participant average among 315 other Schizophrenia trials with a reported enrollment target (95% lower). The listed sponsor is Otsuka Pharmaceutical Development & Commercialization, which has 221 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Schizophrenia appearing as the primary indexed condition, and to 2 interventions - of which SEP-380135 is the first listed.
NCT07305779 reports 1 study location spanning 1 distinct geographic area - top geographies include Kansas.
Frequently Asked Questions
What is clinical trial NCT07305779 about?
NCT07305779 is a clinical study titled "A Trial to Test the Effects of Other Drugs on SEP-380135 in Healthy Men and Women". The purpose of this study is to assess the effect of cytochrome P450 isoenzyme 2D6 (CYP2D6) inhibition by quinidine on the pharmacokinetic (PK) parameters of a single dose SEP-380135 in healthy adult participants.
What is the current status of trial NCT07305779?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2025-03-07. Estimated completion is 2025-05-03.
What conditions does trial NCT07305779 study?
This clinical trial studies the following conditions: Schizophrenia.
What interventions are being tested in trial NCT07305779?
The interventions under investigation include: SEP-380135 (DRUG), Quinidine Gluconate (DRUG).
Who is sponsoring clinical trial NCT07305779?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07305779 being conducted?
This trial has 1 study location across Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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