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NCT01620060 · ClinicalTrials.gov registry record · Phase 1
Lurasidone Pediatric Pharmacokinetics Study
A Phase 1 study, sponsored by Sumitomo Pharma America.
- Completed
- Registry status
- Phase 1
- Development phase
- 105
- Enrollment target
NCT01620060: Completed Phase 1 study, sponsored by Sumitomo Pharma America.
NCT01620060 is a Phase 1 study that has completed, run by Sumitomo Pharma America. The registered enrollment target is 105 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01620060, a Phase 1 study, has completed, sponsored by Sumitomo Pharma America.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 105 participants
- Enrollment target
Study Summary
This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.
Primary Outcome
Lurasidone AUClast (Day 1) and AUC0-∞ (Day 1) AUC0-24 (Day 10 or Day 12)
Interventions
- DRUG Lurasidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 105 participants |
| Start Date | 2012-06 |
| Est. Completion | 2013-05 |
| Phase | Phase 1 |
What the finished NCT01620060 record still lists
NCT01620060 is an interventional study that assigns participants to a tested intervention. The registered 105 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (75% higher).
The record links to 0 conditions, and to 1 intervention - of which Lurasidone is the first listed.
NCT01620060 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01620060 about?
NCT01620060 is a clinical study titled "Lurasidone Pediatric Pharmacokinetics Study". This is a Phase 1, open-label, multicenter, single and multiple ascending lurasidone dose study in subjects from 6 to 17 years old with schizophrenia spectrum, bipolar spectrum, autistic spectrum disorder, or other psychiatric disorders.
What is the current status of trial NCT01620060?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 105 participants. The study started on 2012-06. Estimated completion is 2013-05.
What interventions are being tested in trial NCT01620060?
The interventions under investigation include: Lurasidone (DRUG).
Who is sponsoring clinical trial NCT01620060?
This trial is sponsored by Sumitomo Pharma America, which has 168 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01620060's enrollment target sits among peer trials
105 533rd of 2000 higher than 1,465 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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