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NCT01900522 · ClinicalTrials.gov registry record · Phase 1
Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia
A Phase 1 study, sponsored by Takeda.
- Terminated
- Registry status
- Phase 1
- Development phase
- 76
- Enrollment target
NCT01900522: Clinical Trial Phase 1 study, sponsored by Takeda.
NCT01900522 is a Phase 1 study that was terminated before completion, run by Takeda. The registered enrollment target is 76 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01900522, a Phase 1 study, was terminated before completion, sponsored by Takeda.
- TERMINATED
- Registry status
- Phase 1
- Development phase
- 76 participants
- Enrollment target
Study Summary
The purpose of this study is to characterize the safety and tolerability profile of ITI-214 when administered as multiple doses of oral solution at escalating dose levels.
Primary Outcome
A treatment-emergent adverse event (TEAE) is defined as an adverse event with an onset that occurs after receiving study drug and within 30 days after receiving the last dose of study drug. A TEAE may also be a pre-treatment adverse event or a concurrent medical condition diagnosed prior to the date of first dose of study drug, which increases in intensity after the start of dosing.
Interventions
- DRUG Placebo
- DRUG ITI-214 Dose A
- DRUG ITI-214 Dose B
- DRUG ITI-214 Dose C
- DRUG ITI-214 Dose D (Elderly)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2013-07 |
| Est. Completion | 2014-12 |
| Phase | Phase 1 |
Why NCT01900522 stopped before completion
NCT01900522 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (27% higher).
The record links to 0 conditions, and to 5 interventions - of which Placebo is the first listed.
NCT01900522 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01900522 about?
NCT01900522 is a clinical study titled "Safety and Tolerability of Multiple Doses of ITI-214 in Healthy Adults and in Adults With Stable Schizophrenia". The purpose of this study is to characterize the safety and tolerability profile of ITI-214 when administered as multiple doses of oral solution at escalating dose levels.
What is the current status of trial NCT01900522?
This trial is currently terminated. It is a Phase 1 study. The enrollment target is 76 participants. The study started on 2013-07. Estimated completion is 2014-12.
What interventions are being tested in trial NCT01900522?
The interventions under investigation include: Placebo (DRUG), ITI-214 Dose A (DRUG), ITI-214 Dose B (DRUG), ITI-214 Dose C (DRUG), ITI-214 Dose D (Elderly) (DRUG).
Who is sponsoring clinical trial NCT01900522?
This trial is sponsored by Takeda, which has 408 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01900522's enrollment target sits among peer trials
76 705th of 2000 higher than 1,290 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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