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NCT03489772 · ClinicalTrials.gov registry record · Phase 1
Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement
A Phase 1 study of Healthy Volunteers, sponsored by Intra-Cellular Therapies.
- Completed
- Registry status
- Phase 1
- Development phase
- 26
- Enrollment target
- 1
- Study location
NCT03489772: Completed Phase 1 study of Healthy Volunteers, sponsored by Intra-Cellular Therapies.
NCT03489772 is a Phase 1 study of Healthy Volunteers that has completed, run by Intra-Cellular Therapies. The registered enrollment target is 26 participants, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03489772, a Phase 1 study of Healthy Volunteers, has completed, sponsored by Intra-Cellular Therapies.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 26 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability also will be assessed.
Primary Outcome
Changes in brain activation
Conditions Studied
Interventions
- DRUG Placebo
- DRUG ITI-214
Study Locations (1)
Oklahoma
- Laureate Institute for Brain Research, Inc. - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-07-10 |
| Est. Completion | 2019-08-05 |
| Phase | Phase 1 |
What the finished NCT03489772 record still lists
NCT03489772 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 482-participant average among 283 other Healthy Volunteers trials with a reported enrollment target (95% lower).
The record links to 1 condition, with Healthy Volunteers appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT03489772 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT03489772 about?
NCT03489772 is a clinical study titled "Study of ITI-214 in Healthy Volunteers to Determine CNS Engagement". This is a single site, randomized, double-blind, placebo-controlled, within-subjects study design in healthy volunteers. Escalating single doses of ITI-214 will be evaluated using functional magnetic resonance imaging (fMRI) to determine central nervous system engagement. Safety and tolerability als...
What is the current status of trial NCT03489772?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 26 participants. The study started on 2018-07-10. Estimated completion is 2019-08-05.
What conditions does trial NCT03489772 study?
This clinical trial studies the following conditions: Healthy Volunteers.
What interventions are being tested in trial NCT03489772?
The interventions under investigation include: Placebo (DRUG), ITI-214 (DRUG).
Who is sponsoring clinical trial NCT03489772?
This trial is sponsored by Intra-Cellular Therapies, which has 37 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03489772 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03489772's enrollment target sits among peer trials
26 201st of 283 higher than 81 of 283 other Healthy Volunteers trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Healthy Volunteers 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.
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