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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: Completed Phase 1 study, sponsored by Novartis Pharmaceuticals.
NCT01348100 is a Phase 1 study that has completed, run by Novartis Pharmaceuticals. The registered enrollment target is 81 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher). According to ClinicalTrials.gov, the official US trial registry.
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.
Primary Outcome
Blood samples for pharmacokinetic (PK) evaluation were drawn pre-dose and at 3, 6, and 12 hours on Day 1; at 0 and 12 hours on Day 2; and on Days 3, 4, 6, 8, 10, 14, 18, 22, and 26 following administration of iloperidone. PK parameters were calculated from plasma concentration-time data using non-compartmental methods.
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 |
What the finished NCT01348100 record still lists
NCT01348100 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 81 participants, a relatively small participant target, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (35% higher).
The record links to 0 conditions, and to 3 interventions - of which Iloperidone crystalline formulation is the first listed.
NCT01348100 does not publish any study locations in the registry export this page uses.
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.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01348100's enrollment target sits among peer trials
81 671st of 2000 higher than 1,329 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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