Safety, Tolerability, and Pharmacokinetics of Iloperidone Depot in Schizophrenic Patients

Completed · Phase 1/Phase 2

Conditions studied: Schizophrenia

In brief

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.

Key facts

Study ID

NCT01348100

Run by

Novartis Pharmaceuticals

People needed

81

Starts

2011-04-01

Expected to finish

2012-07-01

Last updated by the study team

2014-01-22

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with schizophrenia that have been stable for 3 months.

You may not qualify if…

• Women who can become or are currently pregnant or lactating.
• Hypersensitivity to iloperidone or related drugs.
• Other protocol-defined inclusion/exclusion criteria may apply.

Where it is running

• Novartis Investigative Site — Glendale, California, United States
• Novartis Investigative Site — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.