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NCT06627413 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder
A Phase 1 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 52
- Enrollment target
NCT06627413 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 52 participants.
The verdict
NCT06627413, a Phase 1 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 52 participants
- Enrollment target
Study Summary
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
Interventions
- DRUG Lumateperone Capsule
- DRUG Lumateperone LAI
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2024-08-23 |
| Est. Completion | 2025-11-20 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06627413
The ClinicalTrials.gov registry entry for NCT06627413 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Intra-Cellular Therapies, which has 37 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Lumateperone Capsule is the first listed.
NCT06627413 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT06627413 about?
NCT06627413 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Lumateperone Long-Acting Injectable Formulations in Patients With Schizophrenia or Schizoaffective Disorder". Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
What is the current status of trial NCT06627413?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 52 participants. The study started on 2024-08-23. Estimated completion is 2025-11-20.
What interventions are being tested in trial NCT06627413?
The interventions under investigation include: Lumateperone Capsule (DRUG), Lumateperone LAI (DRUG).
Who is sponsoring clinical trial NCT06627413?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
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