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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-04-30

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Schizophrenia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Iloperidone 50 mg crystalline formulation - Phase A

Participants received a crystalline formulation of iloperidone 50 mg in a depot intramuscular (IM) injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone crystalline formulation

Intervention Type DRUG

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

Oral iloperidone

Intervention Type DRUG

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.

Iloperidone 125 mg crystalline formulation - Phase A

Participants received a crystalline formulation of iloperidone 125 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 7 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone crystalline formulation

Intervention Type DRUG

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

Oral iloperidone

Intervention Type DRUG

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.

Iloperidone 250 mg crystalline formulation - Phase B

Participants received a crystalline formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone crystalline formulation

Intervention Type DRUG

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

Oral iloperidone

Intervention Type DRUG

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.

Iloperidone 250 mg microparticle formulation - Phase B

Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 1 time. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone microparticle formulation

Intervention Type DRUG

Iloperidone was formulated as microparticles for IM depot injection.

Oral iloperidone

Intervention Type DRUG

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.

Iloperidone 250 mg microparticle formulation - Phase C

Participants received a microparticle formulation of iloperidone 250 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone microparticle formulation

Intervention Type DRUG

Iloperidone was formulated as microparticles for IM depot injection.

Oral iloperidone

Intervention Type DRUG

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.

Iloperidone 500 mg microparticle formulation - Phase C

Participants received a microparticle formulation of iloperidone 500 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone microparticle formulation

Intervention Type DRUG

Iloperidone was formulated as microparticles for IM depot injection.

Oral iloperidone

Intervention Type DRUG

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.

Iloperidone 625 mg microparticle formulation - Phase C

Participants received a microparticle formulation of iloperidone 625 mg in a depot IM injection 2 times 28 days apart. Prior to receiving IM iloperidone, participants were gradually titrated up with oral iloperidone for at least 10 to 14 days to stable doses of 12 to 24 mg daily.

Group Type EXPERIMENTAL

Iloperidone microparticle formulation

Intervention Type DRUG

Iloperidone was formulated as microparticles for IM depot injection.

Oral iloperidone

Intervention Type DRUG

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.

Interventions

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Iloperidone crystalline formulation

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

Intervention Type DRUG

Iloperidone microparticle formulation

Iloperidone was formulated as microparticles for IM depot injection.

Intervention Type 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.

Intervention Type DRUG