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NCT01354353 · ClinicalTrials.gov registry record · Phase 1
A Study of Safety and Tolerability in Subjects With Schizophrenia
A Phase 1 study, sponsored by Denovo Biopharma.
- Completed
- Registry status
- Phase 1
- Development phase
- 75
- Enrollment target
NCT01354353: Completed Phase 1 study, sponsored by Denovo Biopharma.
NCT01354353 is a Phase 1 study that has completed, run by Denovo Biopharma. The registered enrollment target is 75 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01354353, a Phase 1 study, has completed, sponsored by Denovo Biopharma.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 75 participants
- Enrollment target
Study Summary
This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B may be conducted to explore higher doses using titration. Participants in both Parts A and B will participate in a 9 day wash-out period of current medication (Study Days 1-9); participants coming into the study on aripiprazole will remain on their current therapy throughout.
Primary Outcome
Participants with at least 1 postdose (Day 10 through the end of study visit \[Day 21\]) treatment emergent adverse event (TEAE) were counted by dose cohort. A summary of serious and other non-serious adverse events regardless of causality is located in the Reported Adverse Events module.
Interventions
- DRUG Aripiprazole
- DRUG LY2140023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
What the finished NCT01354353 record still lists
NCT01354353 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 75 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (25% higher).
The record links to 0 conditions, and to 2 interventions - of which Aripiprazole is the first listed.
NCT01354353 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01354353 about?
NCT01354353 is a clinical study titled "A Study of Safety and Tolerability in Subjects With Schizophrenia". This is an inpatient, open-label, multiple-dose, multicenter study to evaluate the safety and tolerability of LY2140023 given at doses expected to reflect multiples of the anticipated therapeutic exposure under clinical investigation. In the event of poor tolerability in Part A of this study Part B ...
What is the current status of trial NCT01354353?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 75 participants. The study started on 2011-05. Estimated completion is 2012-03.
What interventions are being tested in trial NCT01354353?
The interventions under investigation include: Aripiprazole (DRUG), LY2140023 (DRUG).
Who is sponsoring clinical trial NCT01354353?
This trial is sponsored by Denovo Biopharma, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01354353's enrollment target sits among peer trials
75 711th of 2000 higher than 1,276 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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