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

• Status: Completed
• Trial end date: 2020-02-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborators: H. Lundbeck A/S; PRA Health Sciences
• Treatments: Aripiprazole

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.