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NCT03292848 · ClinicalTrials.gov registry record · Phase 1
Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders
A Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- Completed
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
NCT03292848: Completed Phase 1 study, sponsored by Otsuka Pharmaceutical Development & Commercialization.
NCT03292848 is a Phase 1 study that has completed, run by Otsuka Pharmaceutical Development & Commercialization. The registered enrollment target is 24 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03292848, a Phase 1 study, has completed, sponsored by Otsuka Pharmaceutical Development & Commercialization.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
Study Summary
A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.
Primary Outcome
The maximum plasma concentration of drug will be assessed for brexpiprazole and its major metabolite DM-3411.
Interventions
- DRUG Brexpiprazole
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2017-10-10 |
| Est. Completion | 2018-05-21 |
| Phase | Phase 1 |
What the finished NCT03292848 record still lists
NCT03292848 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 24 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (60% lower).
The record links to 0 conditions, and to 1 intervention - of which Brexpiprazole is the first listed.
NCT03292848 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03292848 about?
NCT03292848 is a clinical study titled "Trial to Assess the Pharmacokinetics, Safety, Tolerability of Oral Brexpiprazole in Children (6 to <13 Years Old) With Central Nervous System Disorders". A study to assess pharmacokinetics, safety and tolerability of brexpiprazole in children ages 6 to \<13 years with CNS disorders.
What is the current status of trial NCT03292848?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2017-10-10. Estimated completion is 2018-05-21.
What interventions are being tested in trial NCT03292848?
The interventions under investigation include: Brexpiprazole (DRUG).
Who is sponsoring clinical trial NCT03292848?
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 NCT03292848's enrollment target sits among peer trials
24 1520th of 2000 higher than 405 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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