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Keep this study
Lead
Otsuka Pharmaceutical Development & Commercialization, Inc.
With
PRA Health Sciences
H. Lundbeck A/S
Age
18–64
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible 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 be 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.
