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NCT01854944 · ClinicalTrials.gov registry record · Phase 1
PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 12
- Enrollment target
NCT01854944: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT01854944 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 12 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01854944, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 12 participants
- Enrollment target
Study Summary
The purpose of this study is to determine how low and high does of brexpiprazole binds to certain receptors in the brain. This will be determined by PET scans taken pre-dose and post-dose.
Primary Outcome
Dopamine receptor occupancy measured using the radiotracer \[11C\]-(+)-PHNO in low and high dose. The binding of brexpiprazole to the D2/D3 receptors were assessed by comparing the binding potential from the Baseline scan (prior to treatment) to that of Day 10 (after treatment). The D2/D3 receptors following administration of a 1- and 4-mg doses of brexpiprazole were assessed and the occupancy estimates were averaged across brain regions 4 hours post-last dose on Day 10.
Interventions
- DRUG Brexpiprazole 1mg to 4mg
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 12 participants |
| Start Date | 2013-09 |
| Est. Completion | 2014-08 |
| Phase | Phase 1 |
What the finished NCT01854944 record still lists
NCT01854944 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 12 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole 1mg to 4mg is the first listed.
NCT01854944 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01854944 about?
NCT01854944 is a clinical study titled "PET Trial to Assess the Receptor Occupancy of Brexpiprazole in Adult Subjects With Schizophrenia". The purpose of this study is to determine how low and high does of brexpiprazole binds to certain receptors in the brain. This will be determined by PET scans taken pre-dose and post-dose.
What is the current status of trial NCT01854944?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 12 participants. The study started on 2013-09. Estimated completion is 2014-08.
What interventions are being tested in trial NCT01854944?
The interventions under investigation include: Brexpiprazole 1mg to 4mg (DRUG).
Who is sponsoring clinical trial NCT01854944?
This trial is sponsored by Otsuka Pharmaceutical Development & Commercialization, which has 221 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01854944's enrollment target sits among peer trials
12 1852nd of 2000 higher than 90 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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