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

Otsuka

Status and phase: Completed; Phase 1

Conditions: Bipolar I Disorder; Schizophrenia

Treatments: Drug: Aripiprazole

Study type: Interventional

Funder types: Industry

Identifiers

NCT03854409

031-201-00279

Details and patient eligibility

About

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.

Enrollment: 72 patients

Sex: All

Ages: 18 to 64 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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72 participants in 7 patient groups

Part A - Deltoid Site: Single Dose Group

Experimental group

Description:

Participants will receive a single dose of aripiprazole LAI.

Treatment:

Drug: Aripiprazole

Part A - Gluteal Site: Single Dose Group

Experimental group

Description:

Participants will receive a single dose of aripiprazole LAI.

Treatment:

Drug: Aripiprazole

Part A - Deltoid Site: Multiple Dose Group

Experimental group

Description:

Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.

Treatment:

Drug: Aripiprazole

Part A - Gluteal Site: Multiple Dose Group

Experimental group

Description:

Participants will receive five injections of aripiprazole LAI, administered at monthly intervals.

Treatment:

Drug: Aripiprazole

Part B - Gluteal Site: Group 1 (X)

Experimental group

Description:

Participants will receive a single dose of aripiprazole LAI.

Treatment:

Drug: Aripiprazole

Part B - Gluteal Site: Group 1 (Y)

Experimental group

Description:

Participants will receive a single dose of aripiprazole LAI.

Treatment:

Drug: Aripiprazole

Part B - Gluteal Site: Group 2

Experimental group

Description:

Participants will receive a single dose of aripiprazole LAI.

Treatment:

Drug: Aripiprazole