Trial Outcomes & Findings for Food Effect Study of Brexpiprazole Once-weekly (QW) Formulation in Patients With Schizophrenia (NCT NCT06036108)

Last Updated: 2026-02-11

Results Overview

To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state

Recruitment status

COMPLETED

Study phase

PHASE1

Target enrollment

59 participants

Primary outcome timeframe

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

Results posted on

2026-02-11

Participant Flow

This trial was conducted in 59 participants from 26 trial sites in 1 countries.

Adults with schizophrenia as defined by Diagnostic and Statistical Manual of Mental Health Disorders 5th Edition Text Revision criteria were included.

Participant milestones

Participant milestones
Measure	Fasting-state Administration Preceding Group Brexpiprazole QW formulatio in a fasting-state preceding administration	Fed-state Administration Preceding Group Brexpiprazole QW formulatio in a fed-state preceding administration
Overall Study STARTED	29	30
Overall Study COMPLETED	22	23
Overall Study NOT COMPLETED	7	7

Reasons for withdrawal

Reasons for withdrawal
Measure	Fasting-state Administration Preceding Group Brexpiprazole QW formulatio in a fasting-state preceding administration	Fed-state Administration Preceding Group Brexpiprazole QW formulatio in a fed-state preceding administration
Overall Study Adverse Event	4	4
Overall Study Protocol Violation	1	0
Overall Study Withdrawal by Subject	1	2
Overall Study Meets Study-Specific Discontinuation Criteria	1	0
Overall Study Other	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Fasting-state Administration Preceding Group n=29 Participants Brexpiprazole QW formulatio in a fasting-state preceding administration	Fed-state Administration Preceding Group n=30 Participants Brexpiprazole QW formulatio in a fed-state preceding administration	Total n=59 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=41 Participants	30 Participants n=1581 Participants	59 Participants n=4626 Participants
Age, Categorical >=65 years	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Age, Continuous	46.5 Years STANDARD_DEVIATION 10.9 • n=41 Participants	49.8 Years STANDARD_DEVIATION 12.5 • n=1581 Participants	48.2 Years STANDARD_DEVIATION 11.8 • n=4626 Participants
Sex: Female, Male Female	5 Participants n=41 Participants	11 Participants n=1581 Participants	16 Participants n=4626 Participants
Sex: Female, Male Male	24 Participants n=41 Participants	19 Participants n=1581 Participants	43 Participants n=4626 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Asian	29 Participants n=41 Participants	30 Participants n=1581 Participants	59 Participants n=4626 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Black or African American	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) White	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) More than one race	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=41 Participants	0 Participants n=1581 Participants	0 Participants n=4626 Participants
Region of Enrollment Japan	29 Participants n=41 Participants	30 Participants n=1581 Participants	59 Participants n=4626 Participants

PRIMARY outcome

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

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

To evaluate Cmax of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state

Outcome measures

Outcome measures
Measure	Fasting-state Administration n=45 Participants Brexpiprazole QW formulatio in a fasting-state administration	Fed-state Administration n=45 Participants Brexpiprazole QW formulatio in a fed-state administration
Maximum Plasma Concentration (Cmax) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State	221.9 ng/mL Standard Deviation 108.2	365.2 ng/mL Standard Deviation 156.2

PRIMARY outcome

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

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

To evaluate AUC of brexpiprazole following single oral administration of brexpiprazole QW formulation in a fed state versus administration in a fasting state

Outcome measures

Outcome measures
Measure	Fasting-state Administration n=45 Participants Brexpiprazole QW formulatio in a fasting-state administration	Fed-state Administration n=45 Participants Brexpiprazole QW formulatio in a fed-state administration
Area Under Curve (AUC) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State AUC infinity	25400 h∙ng/mL Standard Deviation 16200	37100 h∙ng/mL Standard Deviation 20800
Area Under Curve (AUC) of Brexpiprazole in Plasma After Administration in a Fed State Versus Administration in a Fasting State AUCt	23400 h∙ng/mL Standard Deviation 14100	34700 h∙ng/mL Standard Deviation 18600

Adverse Events

Fasted Stated

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Fed Stated

Serious events: 1 serious events

Other events: 24 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Fasted Stated n=52 participants at risk Brexpiprazole QW formulatio in a fasting-state administration	Fed Stated n=55 participants at risk Brexpiprazole QW formulatio in a fed-state administration
Nervous system disorders Dystonia	0.00% 0/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	1.8% 1/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.

Other adverse events

Other adverse events
Measure	Fasted Stated n=52 participants at risk Brexpiprazole QW formulatio in a fasting-state administration	Fed Stated n=55 participants at risk Brexpiprazole QW formulatio in a fed-state administration
Gastrointestinal disorders Abdominal discomfort	3.8% 2/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	5.5% 3/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
Gastrointestinal disorders Diarrhoea	5.8% 3/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	3.6% 2/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
Gastrointestinal disorders Nausea	9.6% 5/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	12.7% 7/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
Gastrointestinal disorders Vomiting	3.8% 2/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	20.0% 11/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
General disorders Malaise	1.9% 1/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	5.5% 3/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
Infections and infestations Nasopharyngitis	5.8% 3/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	0.00% 0/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
Nervous system disorders Dizziness	1.9% 1/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	9.1% 5/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.
Nervous system disorders Somnolence	9.6% 5/52 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.	12.7% 7/55 • Adverse event are collected after a subject signs the ICF, and continue until the follow-up period, up to 112 days. An AE is defined as any untoward medical occurrence in a clinical trial subject administered a drug used in the clinical trial and which does not necessarily have a causal relationship with this treatment. In this trial, any untoward medical occurrence in a subject not administered a drug used in the clinical trial is also deemed as an AE.

Additional Information

Director of Clinical Trials

Otsuka Pharmaceutical Co.,Ltd.

Phone: 06-6943-7722

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place