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NCT04779177 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder
A Phase 1 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
NCT04779177 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 26 participants.
The verdict
NCT04779177, a Phase 1 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
Study Summary
Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.
Interventions
- DRUG Lumateperone 42 mg
- DRUG Lumateperone 28 mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2021-03-12 |
| Est. Completion | 2022-07-30 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04779177
The ClinicalTrials.gov registry entry for NCT04779177 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 26 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 42 mg is the first listed.
NCT04779177 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04779177 about?
NCT04779177 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Lumateperone in Pediatric Patients With Schizophrenia or Schizoaffective Disorder". Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.
What is the current status of trial NCT04779177?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2021-03-12. Estimated completion is 2022-07-30.
What interventions are being tested in trial NCT04779177?
The interventions under investigation include: Lumateperone 42 mg (DRUG), Lumateperone 28 mg (DRUG).
Who is sponsoring clinical trial NCT04779177?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
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