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

Completed · Phase 1

Conditions studied: Schizophrenia, Bipolar I Disorder

In brief

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.

Key facts

Study ID

NCT03854409

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

72

Starts

2019-01-31

Expected to finish

2020-02-20

Last updated by the study team

2020-09-02

Who can join

Age: 18 and older, up to 64. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Woodland International Research Group — Little Rock, Arkansas, United States
• Collaborative Neuroscience Network — Garden Grove, California, United States
• Hassman Research Institute — Berlin, New Jersey, United States
• Community Clinical Research — Austin, Texas, United States

Full record on ClinicalTrials.gov

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