SchizophreniaPhase 1NCT06036108

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

A Phase 1 study testing OPC-34712FUM/ Brexpiprazole fumarate in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To investigate the effect of food on the pharmacokinetics of a single dose of brexpiprazole QW formulation. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: OPC-34712FUM/ Brexpiprazole fumarate
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 59 participants
Where: 1 siteJapan
Study dates: 3 Oct 2023to 8 Apr 2025
Phase: Phase 1
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 64 years
All sexes
No healthy volunteers
Adult

Who may be able to join

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

Who cannot join

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

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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

Trial locations and contacts

1 site in 1 country.

Japan1 site

Rainbow & Sea Hospital
Saga

Other trials in Japan

About this study

Official title: 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.

Conditions: Schizophrenia
Being tested: OPC-34712FUM/ Brexpiprazole fumarate
Medical subject headings: Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

OPC-34712FUM/ Brexpiprazole fumarateDrug
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.
OPC-34712FUM/ Brexpiprazole fumarateDrug
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.

Study groups in NCT06036108
Study group	Role	What they receive
Fasting-state administration group	Experimental	Brexpiprazole QW formulation in a fasting-state administration Receives: Drug: OPC-34712FUM/ Brexpiprazole fumarate
Fed-state administration group	Experimental	Brexpiprazole QW formulation in a fed-state administration Receives: Drug: OPC-34712FUM/ Brexpiprazole fumarate

What is being measured

The primary outcome is the main question the study is designed to answer.

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
Measured: 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
Measured: PK: Pre-dose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours post-dose

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

3 Oct 20238 Apr 2025

First posted13 Sep 2023
Study start3 Oct 2023
Primary completion18 Mar 2025
Study completion8 Apr 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for SchizophreniaStudies of the same condition, open and under way.
More trials run by Otsuka Pharmaceutical Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 59 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06036108
Sponsor's protocol ID: 331-102-00151
Status last verified: Feb 2026
First submitted: 6 Sep 2023
Last updated: 11 Feb 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: 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.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT06036108
Acronym / sponsor ID: 331-102-00151
Conditions: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 59 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 3 Oct 2023 (actual)
Primary completion: 18 Mar 2025 (actual)
Study completion: 8 Apr 2025 (actual)
First posted: 13 Sep 2023 (actual)
Results: Posted 11 Feb 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Fasting-state administration group	Experimental	Drug: OPC-34712FUM/ Brexpiprazole fumarateBrexpiprazole QW formulation in a fasting-state administration
Fed-state administration group	Experimental	Drug: OPC-34712FUM/ Brexpiprazole fumarateBrexpiprazole QW formulation in a fed-state administration

Who may qualify

Ages: 18 to 64 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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

Key exclusion criteria (11 listed)

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 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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
OPC-34712FUM/ Brexpiprazole fumarateIn 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	Fasting-state administration group
OPC-34712FUM/ Brexpiprazole fumarateIn 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.	Drug	Fed-state administration group

Primary outcome

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
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

Results and safety

Results posted to the registry on 11 Feb 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Fasting-state Administration Preceding Group	29	22
Fed-state Administration Preceding Group	30	23

Primary outcome: 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. Mean (Standard Deviation). Unit: ng/mL

Measure	Fasting-state Administration n = 45	Fed-state Administration n = 45
Value	221.9 (108.2)	365.2 (156.2)

Population analysed: The food effect analysis set includes all subjects for whom Cmax, AUC∞ or AUCt could be calculated throughout Period 1 and Period 2.

Primary outcome: 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. Mean (Standard Deviation). Unit: h∙ng/mL

Measure	Fasting-state Administration n = 45	Fed-state Administration n = 45
AUC infinity	25400 (16200)	37100 (20800)
AUCt	23400 (14100)	34700 (18600)

Population analysed: The food effect analysis set includes all subjects for whom Cmax, AUC∞ or AUCt could be calculated throughout Period 1 and Period 2.

Adverse events

Time frame: Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Fasted Stated	0 of 52 (0%)	15 of 52 (28.8%)	0 of 52
Fed Stated	1 of 55 (1.8%)	24 of 55 (43.6%)	0 of 55

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Takehisa Matsumaru study director

Otsuka Pharmaceutical Co., Ltd.

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing OPC-34712FUM/ Brexpiprazole fumarate in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd. at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 11 Feb 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06036108.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2026.