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

This study has been completed.
Sponsor:
Collaborator:
Vanda Pharmaceuticals
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01348100
First received: April 28, 2011
Last updated: December 17, 2013
Last verified: December 2013
Results First Received: July 25, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Pharmacokinetics Study;   Intervention Model: Parallel Assignment;   Masking: Open Label;   Primary Purpose: Treatment
Condition: Schizophrenia
Interventions: Drug: Iloperidone crystalline formulation
Drug: Iloperidone microparticle formulation
Drug: Oral iloperidone

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
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.
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.
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.
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.
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.
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.
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.

Participant Flow:   Overall Study
    Iloperidone 50 mg Crystalline Formulation - Phase A     Iloperidone 125 mg Crystalline Formulation - Phase A     Iloperidone 250 mg Crystalline Formulation - Phase B     Iloperidone 250 mg Microparticle Formulation - Phase B     Iloperidone 250 mg Microparticle Formulation - Phase C     Iloperidone 500 mg Microparticle Formulation - Phase C     Iloperidone 625 mg Microparticle Formulation - Phase C  
STARTED     2     2     15     15     15     16     16  
COMPLETED     2     2     13     14     14     14     13  
NOT COMPLETED     0     0     2     1     1     2     3  
Subject Withdrew Consent                 0                 0                 2                 0                 1                 0                 1  
Protocol Deviation                 0                 0                 0                 1                 0                 0                 0  
Unsatisfactory Therapeutic Effect                 0                 0                 0                 0                 0                 1                 0  
Lost to Follow-up                 0                 0                 0                 0                 0                 0                 1  
Administrative Problems                 0                 0                 0                 0                 0                 1                 1  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Safety population: All participants who received at least 1 dose of study drug and had at least 1 post-baseline safety assessment.

Reporting Groups
  Description
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.
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.
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.
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.
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.
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.
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.
Total Total of all reporting groups

Baseline Measures
    Iloperidone 50 mg Crystalline Formulation - Phase A     Iloperidone 125 mg Crystalline Formulation - Phase A     Iloperidone 250 mg Crystalline Formulation - Phase B     Iloperidone 250 mg Microparticle Formulation - Phase B     Iloperidone 250 mg Microparticle Formulation - Phase C     Iloperidone 500 mg Microparticle Formulation - Phase C     Iloperidone 625 mg Microparticle Formulation - Phase C     Total  
Number of Participants  
[units: participants]
  2     2     15     15     15     16     16     81  
Age  
[units: years]
Mean ± Standard Deviation
  42.0  ± 2.83     35.5  ± 12.02     45.5  ± 14.81     43.5  ± 13.02     42.3  ± 10.62     41.3  ± 10.03     45.1  ± 11.21     43.3  ± 11.60  
Gender  
[units: participants]
               
Female     0     2     5     4     6     5     3     25  
Male     2     0     10     11     9     11     13     56  



  Outcome Measures
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1.  Primary:   Maximum Observed Plasma Concentration (Cmax) of Iloperidone Divided by the Average Plasma Concentration (Cav) of Iloperidone (Cmax/Cav) - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

2.  Primary:   The Average Plasma Concentration (Cav) of Iloperidone - Phase C   [ Time Frame: Pre-dose to 26 days post-dose ]

3.  Secondary:   Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

4.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

5.  Secondary:   Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

6.  Secondary:   Area Under the Plasma Concentration-time Curve From 0 to the Last Measurable Concentration (AUClast) of Iloperidone - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

7.  Secondary:   The Average Plasma Concentration (Cav) of Iloperidone - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

8.  Secondary:   Duration That the Concentration of Iloperidone Was Above 4 ng/mL (Teff) - Phase B   [ Time Frame: Pre-dose to 26 days post-dose ]

9.  Secondary:   Time to Reach the Maximum Plasma Concentration (Tmax) of Iloperidone - Phase C   [ Time Frame: Pre-dose to 26 days post-dose ]

10.  Secondary:   Maximum Observed Plasma Concentration (Cmax) of Iloperidone - Phase C   [ Time Frame: Pre-dose to 26 days post-dose ]

11.  Secondary:   Area Under the Plasma Concentration-time Curve From 0 to the End of the Dosing Period (AUCtau) of Iloperidone - Phase C   [ Time Frame: Pre-dose to 26 days post-dose ]

12.  Secondary:   The Average Plasma Concentration (Cav) of Iloperidone Divided by Dose - Phase C   [ Time Frame: Pre-dose to 26 days post-dose ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862 778-8300


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
Results First Received: July 25, 2013
Last Updated: December 17, 2013
Health Authority: United States: Food and Drug Administration