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NCT01348100 · ClinicalTrials.gov registry record · Phase 1
Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
A Phase 1 study, sponsored by Novartis Pharmaceuticals.
- Completed
- Registry status
- Phase 1
- Development phase
- 81
- Enrollment target
NCT01348100 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 81 participants.
The verdict
NCT01348100, a Phase 1 study, has completed, sponsored by Novartis Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 81 participants
- Enrollment target
Study Summary
This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline iloperidone depot formulation. In Phase B, the pharmacokinetic and safety profile of 2 depot clinical dosage forms will be compared, and 1 form will be selected for assessment in Phase C. Phase C of this study is designed to define the dose-exposure relationship of the selected form and to provide information that will permit a comparison of the risk-benefit ratio of several doses of the study drug to enable optimal dose selection for later studies.
Interventions
- DRUG Iloperidone crystalline formulation
- DRUG Iloperidone microparticle formulation
- DRUG Oral iloperidone
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 81 participants |
| Start Date | 2011-04 |
| Est. Completion | 2012-07 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01348100
The ClinicalTrials.gov registry entry for NCT01348100 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 81 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novartis Pharmaceuticals, which has 1,375 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Iloperidone crystalline formulation is the first listed.
NCT01348100 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT01348100 about?
NCT01348100 is a clinical study titled "Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients". This study is designed as a 3-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare 2 depot dosage forms, and perform dose ranging of 1 chosen form in support of a monthly depot dosing regimen. In Phase A, the study is designed to evaluate the safety of a crystalline...
What is the current status of trial NCT01348100?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 81 participants. The study started on 2011-04. Estimated completion is 2012-07.
What interventions are being tested in trial NCT01348100?
The interventions under investigation include: Iloperidone crystalline formulation (DRUG), Iloperidone microparticle formulation (DRUG), Oral iloperidone (DRUG).
Who is sponsoring clinical trial NCT01348100?
This trial is sponsored by Novartis Pharmaceuticals, which has 1,375 total clinical trials registered on ClinicalTrials.gov.
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