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NCT04709224 · ClinicalTrials.gov registry record · Phase 1
Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia
A Phase 1 study, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 37
- Enrollment target
NCT04709224 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 37 participants.
The verdict
NCT04709224, a Phase 1 study, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 37 participants
- Enrollment target
Study Summary
This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to four cohorts. All patients will receive oral lumateperone for 5 days, followed by a 5-day washout of oral lumateperone, then followed by a single dose of lumateperone LAI.
Interventions
- DRUG Lumateperone Long-Acting Injectable
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 37 participants |
| Start Date | 2020-12-30 |
| Est. Completion | 2022-05-23 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04709224
The ClinicalTrials.gov registry entry for NCT04709224 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 37 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 1 intervention - of which Lumateperone Long-Acting Injectable is the first listed.
NCT04709224 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04709224 about?
NCT04709224 is a clinical study titled "Pharmacokinetics, Safety, and Tolerability of Lumateperone Long-Acting Injectable in Patients With Schizophrenia". This is an open-label study to determine the pharmacokinetics, safety and tolerability of single ascending doses of lumateperone long-acting injectable formulation in patients with schizophrenia. Patients will be enrolled in one of up to four cohorts. All patients will receive oral lumateperone for ...
What is the current status of trial NCT04709224?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 37 participants. The study started on 2020-12-30. Estimated completion is 2022-05-23.
What interventions are being tested in trial NCT04709224?
The interventions under investigation include: Lumateperone Long-Acting Injectable (DRUG).
Who is sponsoring clinical trial NCT04709224?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
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