Safety, Tolerability and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients
This study has been completed.
Sponsor:
Novartis Pharmaceuticals
Collaborator:
Vanda Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01348100
First received: April 28, 2011
Last updated: March 13, 2013
Last verified: March 2013
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Purpose
This study is designed as a three-part trial to evaluate the safety of a novel depot formulation of iloperidone, compare two depot dosage forms, and perform dose ranging of one 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 two depot clinical dosage forms will be compared, and one 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.
| Condition | Intervention | Phase |
|---|---|---|
|
Schizophrenia |
Drug: Iloperidone |
Phase 1 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | An Open-label Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of Two Iloperidone Depot Formulations Followed by a Dose-ranging Phase of One Selected Formulation in Schizophrenic Patients Given Depot Injections Every 28 Days |
Resource links provided by NLM:
MedlinePlus related topics:
Schizophrenia
Drug Information available for:
Iloperidone
U.S. FDA Resources
Further study details as provided by Novartis:
Primary Outcome Measures:
- Safety and tolerability of iloperidone depot formulations as measured by adverse events, clinical safety labs, vital signs, electrocardiograms (ECGs), and injection site assessments [ Time Frame: up to 42 days after injection ] [ Designated as safety issue: Yes ]
Secondary Outcome Measures:
- Pharmacokinetic profile of iloperidone depot formulations as measured by concentrations of iloperidone in the blood [ Time Frame: up to 42 days after injection ] [ Designated as safety issue: No ]
| Enrollment: | 168 |
| Study Start Date: | April 2011 |
| Study Completion Date: | July 2012 |
| Primary Completion Date: | July 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| Experimental: Iloperidone 250 mg crystalline depot | Drug: Iloperidone |
| Experimental: Iloperidone 125 mg crystalline depot | Drug: Iloperidone |
| Experimental: Iloperidone 250 mg microparticle depot | Drug: Iloperidone |
| Experimental: Iloperidone low dose depot | Drug: Iloperidone |
| Experimental: Iloperidone medium dose depot | Drug: Iloperidone |
| Experimental: Iloperidone high dose depot | Drug: Iloperidone |
| Experimental: Iloperidone 50 mg crystalline depot | Drug: Iloperidone |
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with schizophrenia that have been stable for 3 months
Exclusion Criteria:
- Women who can become or are currently pregnant or lactating
- Hypersensitivity to iloperidone or related drugs
Other protocol-defined inclusion/exclusion criteria may apply
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01348100
Locations
| United States, California | |
| Novartis Investigative Site | |
| Glendale, California, United States, 91206 | |
| United States, Pennsylvania | |
| Novartis Investigative Site | |
| Philadelphia, Pennsylvania, United States, 19149 | |
Sponsors and Collaborators
Novartis Pharmaceuticals
Vanda Pharmaceuticals
Investigators
| Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
More Information
No publications provided
| Responsible Party: | Novartis ( Novartis Pharmaceuticals ) |
| ClinicalTrials.gov Identifier: | NCT01348100 History of Changes |
| Other Study ID Numbers: | CILO522E2101 |
| Study First Received: | April 28, 2011 |
| Last Updated: | March 13, 2013 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Novartis:
|
Schizophrenia Iloperidone Depot Injection |
Additional relevant MeSH terms:
|
Schizophrenia Schizophrenia and Disorders with Psychotic Features Mental Disorders |
ClinicalTrials.gov processed this record on May 22, 2013