A Trial of Single- and Multiple-doses of Aripiprazole in Adult Subjects With Schizophrenia or Bipolar I Disorder

Study Identifier:
031-201-00279
ClinicalTrials.gov Identifier:
NCT03854409
EudraCT Identifier:
N/A
EU CT ID:
N/A
Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information:
N/A
Study Complete
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Study Details

Medical Condition
  • Schizophrenia
  • Bipolar Disorder
Study Drug
  • Drug: Aripiprazole
Date
Jan 2019 - Apr 2019
Phase 1/2
Phase 2/3
Phase 1
Phase 2
Phase 3
Phase 4
N/A
Patient Requirements
Sex: Female & Male
Age: 18 - 64 Years
Requirements Information
Inclusion and Exclusion Criteria
Inclusion Criteria
  • Male and female subjects between 18 and 64 years of age, inclusive.
  • Body mass index of 18 to 35 kg/m2, inclusive.
  • A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
  • Prior history of tolerating aripiprazole per investigator's judgment.
Exclusion Criteria
  • Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Subjects may not receive varenicline beyond screening.
  • Use of any prescription medication not specifically approved by the medical monitor.
  • Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
  • Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
  • Subjects currently in an acute relapse of schizophrenia.
  • Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
  • Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • Subjects deemed intolerant of receiving injections.

Protocol Summary

The primary objective of this trial is to evaluate the pharmacokinetics (PK) of aripiprazole long-acting injectable (LAI) (420 mg) following deltoid or gluteal muscle administration in adult subjects with schizophrenia or bipolar I disorder.

Study Locations

Location
Status
Location
Woodland International Research Group
Little Rock, Arkansas, United States, 72211
Status
N/A
Location
Collaborative Neuroscience Network
Garden Grove, California, United States, 92845
Status
N/A
Location
Hassman Research Institute
Berlin, New Jersey, United States, 08009
Status
N/A
Location
Community Clinical Research
Austin, Texas, United States, 78754
Status
N/A
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All rights reserved.

July 2025 01US25EUC0279

Requirements information
Inclusion criteria
  • Male and female subjects between 18 and 64 years of age, inclusive.
  • Body mass index of 18 to 35 kg/m2, inclusive.
  • A current diagnosis of schizophrenia or a current diagnosis of bipolar I disorder as defined by DSM-5 criteria.
  • Prior history of tolerating aripiprazole per investigator's judgment.
Exclusion criteria
  • Subjects who have met DSM-5 criteria for substance dependence within the past 180 days
  • Use of any psychotropic medications other than their current non-aripiprazole antipsychotic or mood stabilizer(s) medication or subjects who use more than one antipsychotic or mood stabilizer(s) medication at screening.
  • Subjects may not receive varenicline beyond screening.
  • Use of any prescription medication not specifically approved by the medical monitor.
  • Females who are pregnant or lactating. A negative serum pregnancy test must be confirmed prior to the first dose of IMP for all female subjects.
  • Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to enrollment; subjects who had participated in a previous aripiprazole LAI trial within the last 1 year (ie, enrolled but did not receive aripiprazole LAI); or who had previously enrolled and received IMP in an aripiprazole LAI clinical trial.
  • Any major surgery within 30 days prior to enrollment or scheduled/elective surgery during the trial.
  • Subjects currently in an acute relapse of schizophrenia.
  • Subjects with a current DSM-5 diagnosis other than schizophrenia or bipolar I disorder
  • Electroconvulsive therapy must not be conducted within 2 months prior to administration of the IMP
  • Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
  • History of or current hepatitis or acquired immunodeficiency syndrome or carriers of HBsAg, anti-HCV, and/or HIV antibodies.
  • History of any significant drug allergy or known or suspected hypersensitivity, in particular to aripiprazole or other quinolinones.
  • Subjects deemed intolerant of receiving injections.

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