Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

February 9, 2026 updated by: Otsuka Pharmaceutical Co., Ltd.

A Multicenter, Randomized, Open-label, 2-arm, 2-period Crossover Trial to Investigate the Effects of Food on the Pharmacokinetics of a Single Dose of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia

To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

59

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Saga, Japan
        • Rainbow & Sea Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with a diagnosis of schizophrenia based on DSM-5® at the time of informed consent
  • Patients who are able to be hospitalized for the protocol-defined hospitalization period
  • Patients with a body mass index [BMI = body weight (kg)/height (m)²] of 18.5 kg/m² or higher and lower than 35.0 kg/m² at screening
  • Patients who, in the judgment of the investigator, have stable psychotic symptoms maintained by administration of an antipsychotic within the dosing range indicated below, before commencement of IMP administration [Upper limit of dose and regimen] Antipsychotic medication comprising no more than 2 active components, and a daily dose equivalent to ≤600 mg/day of chlorpromazine
  • Patients who are able to finish the high-fat meal specified in this protocol within 20 minutes

Exclusion Criteria:

  • Patients with a concurrent mental disorder besides schizophrenia who are judged by the investigator to be unsuitable for participation in the trial
  • Patients who have met the DSM-5® diagnostic criteria for substance-related or addictive disorder, including alcohol and benzodiazepines but excluding caffeine and tobacco, within 180 days before commencement of investigational medicinal product (IMP) administration

  • Patients who fall under any of the following criteria regarding suicidal ideation and suicidal behavior

    • Patients who answered "yes" to Question 4 "Active Suicidal Ideation with Some Intent to Act, without Specific Plan" or Question 5 "Active Suicidal Ideation with Specific Plan and Intent" regarding C-SSRS suicidal ideation at screening (for the past 6 months) or at the Period 1 baseline examination (since the last assessment)
    • Patients who exhibited suicidal behavior on C-SSRS at screening (for the past 2 years) or at the Period 1 baseline examination (since the last assessment)
    • Patients who present a serious risk of suicide based on the judgment of the investigator
  • Patients who have previously undergone gastrointestinal surgery that could affect PK evaluation
  • Patients who have a clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorder. Medical conditions that are minor or well-controlled may be considered acceptable if the condition does not interfere with safety and PK assessments.
  • Patients who are using clozapine at the time of informed consent
  • Patients whose clinical symptoms have worsened to the point where use of prohibited concomitant therapy or medication is required during the washout period for prior medication
  • Patients whose cytochrome P450 2D6 (CYP2D6) phenotype is judged to be either poor metabolizers (PM) or Unknown based on the results of CYP2D6 genotyping at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Fasting-state administration group
Brexpiprazole QW formulation in a fasting-state administration
Drug: OPC-34712FUM/ Brexpiprazole fumarate
In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.
Drug: OPC-34712FUM/ Brexpiprazole fumarate
In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.
Experimental: Fed-state administration group
Brexpiprazole QW formulation in a fed-state administration
Drug: OPC-34712FUM/ Brexpiprazole fumarate
In Period 1, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered at least 10 hours of fasting. In Period 2, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal.
Drug: OPC-34712FUM/ Brexpiprazole fumarate
In Period 1, following at least 10 hours of fasting, the subject will consume a high-fat meal within 20 minutes, after which a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered within 10 minutes of finishing the meal. In Period 2, a single oral dose of two 24 mg tablets of brexpiprazole QW formulation (48 mg as brexpiprazole) will be administered following at least 10 hours of fasting.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Plasma Concentration (Cmax) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State
Time Frame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state
PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
Area Under Curve (AUC) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State
Time Frame: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose
To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state
PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Investigators

  • Study Director: Takehisa Matsumaru, Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 3, 2023

Primary Completion (Actual)

March 18, 2025

Study Completion (Actual)

April 8, 2025

Study Registration Dates

First Submitted

September 6, 2023

First Submitted That Met QC Criteria

September 6, 2023

First Posted (Actual)

September 13, 2023

Study Record Updates

Last Update Posted (Actual)

February 11, 2026

Last Update Submitted That Met QC Criteria

February 9, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331-102-00151

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Anonymized Individual participant data (IPD) that underlie the results of this study will be shared with researchers to achieve aims pre-specified in a methodologically sound research proposal.

IPD Sharing Time Frame

Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.

IPD Sharing Access Criteria

Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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