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

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

81

Participants

Timeline

Start Date

April 30, 2011

Primary Completion Date

July 31, 2012

Study Completion Date

July 31, 2012

Conditions
Schizophrenia
Interventions
DRUG

Iloperidone crystalline formulation

Iloperidone was formulated as 100 µm crystals for IM depot injection.

DRUG

Iloperidone microparticle formulation

Iloperidone was formulated as microparticles for IM depot injection.

DRUG

Oral iloperidone

Prior to receiving an intramuscular (IM) injection of iloperidone, patients were gradually titrated up with oral iloperidone to stable doses of 12 to 24 mg daily. In Phase A, oral iloperidone dosing lasted for at least 7 days and, in Phases B and C, for at least 10 to 14 days.

Trial Locations (2)

19149

Novartis Investigative Site, Philadelphia

91206

Novartis Investigative Site, Glendale

Sponsors
All Listed Sponsors
collaborator

Vanda Pharmaceuticals

INDUSTRY

lead

Novartis Pharmaceuticals

INDUSTRY