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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 is a Phase 1 study that has completed, run by Denovo Biopharma. The registered enrollment target is 75 participants.
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.
Interventions
- DRUG Aripiprazole
- DRUG LY2140023
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 75 participants |
| Start Date | 2011-05 |
| Est. Completion | 2012-03 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01354353
The ClinicalTrials.gov registry entry for NCT01354353 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 75 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Denovo Biopharma, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Aripiprazole is the first listed.
NCT01354353 reports 0 study locations.
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.
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