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

Sponsor ID
031-201-00279
Clinicaltrials.gov ID
NCT03854409
EudraCT ID
N/A
EUCTIS ID
N/A
Sponsor
Otsuka Pharmaceutical Development & Commercialization, Inc.
Study Contact Information
N/A
Study Complete
Sponsor ID
031-201-00279
Trial Details
Subscribe for updates
Age
18 - 64 Years
Therapeutic Area
  • Schizophrenia
  • Bipolar Disorder
    • Sex
    Female & Male
    Trial Dates
    Jan 2019 - Apr 2019
    Healthy Volunteers
    No
    • 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.
    • 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.

    Study 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.

    Additional Study Details

    Phase
    Phase 1
    Study Drug
    Drug: Aripiprazole
    Type
    Interventional
    Masking
    None (Open Label)
    Estimated Enrollment
    72
    Additional Study Details

    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.

    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.
    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.

    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

    © 2026 Otsuka America Pharmaceutical, Inc.

    All rights reserved.

    January 2026 01US25EUC0489

    We defy limitation,

    so that others can too.

    Follow Us
    OAPI and OPDC Locations

    508 Carnegie Center Dr,

    Princeton, NJ 08540, United States

    Phone +1 609-524-6788

    2440 Research Blvd,

    Rockville, MD 20850, United States

    Phone +1 301-424-9055

    3956 Point Eden Way

    Hayward, CA 94545, United States

    Phone +1 800-562-3974