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

Conditions:Schizophrenia, Psychiatric, Bipolar Disorder
Therapuetic Areas:Psychiatry / Psychology
Age Range:18 - 64
Start Date:January 31, 2019
End Date:December 2019
Contact:Stefanie Bjerregaard
Phone:+1 801-904-4836

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An Open-label, Single- and Multiple-dose, Pharmacokinetic, Safety, and Tolerability Trial of Aripiprazole Long-acting Injectable Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia or Bipolar I Disorder

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.

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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