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

NCT06036108 | Completed Phase 1 Results

• 1 other identifier: 331-102-00151
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Schizophrenia

Outcome Measures

Primary Outcomes (2)

• Maximum Plasma Concentration (Cmax) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State

  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

  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

Study Arms (2)

Fasting-state administration group

EXPERIMENTAL

Brexpiprazole QW formulation in a fasting-state administration

Drug: OPC-34712FUM/ Brexpiprazole fumarate

Fed-state administration group

EXPERIMENTAL

Brexpiprazole QW formulation in a fed-state administration

Drug: OPC-34712FUM/ Brexpiprazole fumarate

Interventions

OPC-34712FUM/ Brexpiprazole fumarate DRUG

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.

Fasting-state administration group

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Rainbow & Sea Hospital

Saga, Japan

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co.,Ltd.

CL_OPCJ_RDA_Team@otsuka.jp

06-6943-7722

Study Officials

• Takehisa Matsumaru

  Otsuka Pharmaceutical Co., Ltd.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 6, 2023
• First Posted: September 13, 2023
• Study Start: October 3, 2023
• Primary Completion: March 18, 2025
• Study Completion: April 8, 2025
• Last Updated: February 11, 2026
• Results First Posted: February 11, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• 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.
• 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.

Locations

JP (1)