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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: Completed Phase 1 study, sponsored by Intra-Cellular Therapies.
NCT04709224 is a Phase 1 study that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 37 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
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 |
What the finished NCT04709224 record still lists
NCT04709224 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 37 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which Lumateperone Long-Acting Injectable is the first listed.
NCT04709224 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04709224's enrollment target sits among peer trials
37 1204th of 2000 higher than 791 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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