SchizophreniaPhase 2/3NCT07742280
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brexpiprazole for Extended-Release Injection in Subjects With Schizophrenia
A Phase 2/3 study testing Brexpiprazole for ER injection, 45 mg and Brexpiprazole for ER injection, 100 mg in people with Schizophrenia, run by Bostal Drug Delivery Co., Ltd.
Trial summary
This study is to evaluate the pharmacokinetics (PK), safety and tolerability of Brexpiprazole, administered subcutaneously, in subjects with schizophrenia. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Schizophrenia
- What is being tested?
- Brexpiprazole for ER injection, 45 mg and Brexpiprazole for ER injection, 100 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- Aug 2026to Dec 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects and/or subject's legally acceptable representative (LAR) is able to sign informed consent and subject is willing to comply with the trial protocol and to attend the clinic visits.
- Male or female subjects diagnosed with schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria.
- Subjects with a Clinical Global Impression-Severity of Illness (CGI-S) Score of ≤ 4 at screening and on enrolment prior to IP dosing (Day -1).
- Subjects with Positive and Negative syndrome-scale (PANSS) total score ≤75 at screening and on enrolment prior to IP dosing (Day -1).
- Subjects aged 18-65 years (both inclusive) having Body Mass Index (BMI) between 18.50 to 30.00 kg/m2
- Schizophrenic subjects who are clinically stable on their current antipsychotic medication other than Brexpiprazole, for a duration of at least 8 weeks prior to screening. [Refer to Appendix A for List of Allowable medications] NOTE: Subjects must NOT be taking > 2 antipsychotic medications for their disease
Show all 26Show fewer
- Subjects who have tolerated oral Brexpiprazole prior to dosing.
- Subjects with acceptable haematology status:
- Hemoglobin ≥ 9 g/dL
- Absolute neutrophil count (ANC) ≥ 1500 cells/μL
- Platelet count ≥ 100,000 cells/μL
- White blood cell count (WBC) ≥ 4000 cells/μL
- Subjects with acceptable liver function:
- Alanine aminotransferase (ALT) ≤ 2 X upper limit of normal (ULN)
- Aspartate aminotransferase (AST) ≤ 2 X ULN
- Bilirubin < 1.5 X ULN
- Alkaline phosphatase ≤ 2 X ULN
- Subjects with creatinine clearance ≥ 60 mL/minute (using the Cockcroft- Gault Equation).
- Female subjects of childbearing potential with negative pregnancy test at screening and at enrolment day, and agree to practice acceptable methods of contraception during the study.
- Acceptable methods of contraception are:
- Oral or other (e.g. injection, patch or implant) hormonal contraception which has been used continuously for at least one month prior to the first dose of study medication
- Intrauterine device (IUD) or intrauterine system (IUS)
- Double barrier method of contraception (condom and occlusive cap or condom and spermicidal agent)
- Female sterilization (surgical bilateral oophorectomy) or tubal ligation at least 6 weeks prior to study participation
- Subjects who agree to avoid drinking alcohol during the study.
- Subjects with accessible vein access from arm.
Who cannot join
- Subjects with known hypersensitivity to Brexpiprazole or related class of drugs or to any of the excipients of the formulation.
- Subjects currently in acute, manic episodes of schizophrenia, as assessed by the Investigator.
- Subjects with history of or a current DSM-5-TR diagnosis of concurrent mental disorder besides schizophrenia (e.g., schizoaffective-disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder).
- Subjects who have any suicidal ideation based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on any of the questions of 'Suicidal Ideation' on the CSSRS for screening. [Refer to Appendix B]
- Subjects with history or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, Parkinson's disease, epilepsy or other seizure disorders, cognitive and motor impairment, pathological gambling, dysphagia or other compulsive behaviour
- Subjects with a prior personal or family history of dystonic reactions to medications.
Show all 26Show fewer
- Subjects with clinically significant dyslipidemia.
- Subjects with a history of syncope or a presence of significant orthostatic hypotension (i.e., a drop in systolic blood pressure of 20 mm Hg or more and/or a drop in diastolic blood pressure of 10 mm Hg or more within 3 minutes of standing from a minimum of 5 minutes in supine position) at screening.
- Subjects with known history or presence of any systemic disease (e.g., cardiovascular disease, cerebrovascular disease, diabetes mellitus, etc.)
- Subject who are on concurrent treatment with other anti-psychotic Longacting Injection (LAIs).
- Subject who has received concomitant medications that are strong CYP3A4 inhibitors, CYP2D6 inhibitors, or CYP3A4 inducers within 14 days prior to study drug administration (or within five half-lives since the last drug administration, whichever is greater), or is expected to require such treatment during the study.
- Subjects with any other medical condition or serious inter-current illness that, in the opinion of the Investigator, may make it undesirable for the subject to participate in the study including but not limited to cirrhosis or psychiatric illness other than schizophrenia /social situations that would limit adherence to study requirements.
- Any other condition(s) which could significantly interfere with protocol compliance
- Subjects found positive for urine screen for drugs of abuse (except for benzodiazepine, which is a permissible medication if supported by prescription)
- Subjects with major surgical procedure (including periodontal) within 28 days of IP dosing or plan to have major surgical procedure during the study
- Subjects with current surgical or other non-healing wounds.
- Subjects who have participated in any clinical trial with another investigational drug or other investigational intervention within 90 days of enrolment.
- Loss of ≥ 350 mL (1 unit) of blood within 90 days before enrolment in the study.
- Subjects with history of difficulty with donating blood or difficulty in accessibility of veins.
- Subjects with positive serology for Hepatitis B surface antigen (HBsAg), Hepatitis B core antibody (HBcAb), Hepatitis C Virus (HCV), or Human Immunodeficiency Virus (HIV).
- Note: Subjects with Hepatitis B core antibody (HBcAb) positive result can be enrolled if a confirmatory negative test is obtained suggestive of no active infection currently.
- Alcoholics (alcohol consumption of more than 14 units per week for men and more than 7 units per week for women, each unit equivalent to 360 mL of beer or 150 mL of wine or 45 mL of spirits with 40% alcohol content) or those who have a positive urine alcohol test
- Subjects who have consumed tobacco-containing products (smoking, tobacco chewing, etc.), xanthine containing food, poppy seeds, and beverages (chocolates, tea, coffee, or cola drinks) or alcohol within 48.00 hours (02 days) prior to receiving the first dose of oral Brexpiprazole tablets for the tolerability assessment period (on Day -44) and within 48.00 hours (02 days) prior to IP dosing (on Day 1) or subject who is not ready to abstain from them till the last PK sample collection for oral Brexpiprazole tablets (on Day -27) and till 30 days after the IP administration on Day 1.
- Subjects who have consumed grapefruit or its juice and cranberry juice within 96.00 hours (04 days) prior to dosing or subject who is not ready to abstain from them till last study-related procedure.
- Subjects currently smoking greater than or equal to 10 cigarettes or equivalent per day.
- Pregnant or lactating women
About this study
Official title: An Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brexpiprazole for Extended-Release Injection Administered as a Single Dose in Subjects With Schizophrenia
This study is to evaluate the pharmacokinetics (PK), safety and tolerability of Brexpiprazole, administered subcutaneously, in subjects with schizophrenia.
- Conditions
- Schizophrenia
- Being tested
- Brexpiprazole for ER injection, 45 mg, Brexpiprazole for ER injection, 100 mg
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brexpiprazole for ER injection, 45 mgDrug
Single-dose, Subcutaneous
Brexpiprazole for ER injection, 100 mgDrug
Single-dose, Subcutaneous
| Study group | Role | What they receive |
|---|---|---|
| Brexpiprazole for ER injection, 45 mg | Experimental | Not described Receives: Drug: Brexpiprazole for ER injection, 45 mg |
| Brexpiprazole for ER injection, 100 mg | Experimental | Not described Receives: Drug: Brexpiprazole for ER injection, 100 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cmax
Maximum peak plasma concentration
Measured: Pre-dose to 190 days post-dose
Clast
Last measurable plasma concentration
Measured: Pre-dose to 190 days post-dose
Tmax
Time of occurence of Cmax
Measured: Pre-dose to 190 days post-dose
AUC0-last
Area under curve from time zero to last measurable concentration
Measured: Pre-dose to 190 days post-dose
Kel
Measured: Pre-dose to 190 days post-dose
T1/2
Half-life
Measured: Pre-dose to 190 days post-dose
Vd/F
Volume of distribution
Measured: Pre-dose to 190 days post-dose
CL/F
Apparent clearance of drug from plasma
Measured: Pre-dose to 190 days post-dose
MRT
Mean residence time of the drug in the body
Measured: Pre-dose to 190 days post-dose
AUC_%Extrap_obs
Percentage of AUC due to extrapolation from Tlast to infinity
Measured: Pre-dose to 190 days post-dose
AEs
Adverse events
Measured: Day 1 to Day 190
SAEs
Serious AEs
Measured: Day 1 to Day 190
Change from baseline in physical examination findings
Change from baseline in clinical physical examination findings will be assessed descriptively for safety monitoring. The assessment includes general appearance, skin, head, ears, eyes, nose and throat, chest and lungs, cardiovascular, abdomen, musculoskeletal and extremities, neurological, psychiatric, and mental status examinations. Individual findings will be evaluated for clinically meaningful changes from baseline.
Measured: Day 1 to Day 190
Blood Pressure
Evaluate the clinical significance of test value outside of the reference range.
Measured: Day 1 to Day 190
Orthostatic hypotension
Drop in blood pressure due to a change in body position from standing to supine
Measured: Day 1 to Day 190
Columbia-Suicide Severity Rating Scale (C-SSRS) assessment
Change in suicidality from baseline.
Measured: Day 1 to Day 190
Clinical Laboratory Tests
Evaluate the clinical significance of each test value outside of the reference range. Lab tests including blood test for Human immunodeficiency virus (HIV), Hepatitis B virus (HBsAg and HBcAb) and Hepatitis C virus (HCV), haematology (Total WBC count, total RBC count, hemoglobin, HCT (PCV), lymphocytes, monocytes, granulocytes, platelet count, and ANC), biochemistry (Fasting blood glucose, BUN, serum creatinine, creatinine clearance, total bilirubin, SGPT, SGOT, ALP, serum cholesterol, sodium, calcium, potassium, chloride, magnesium, LDL, HDL and TG), serum pregnancy test (only for females of childbearing potential) and urine test
Measured: Day 1 to Day 190
12-lead ECG Assessment
For safety assessment. ECG findings will be evaluated descriptively based on the overall interpretation (Normal, Abnormal Not Clinically Significant [NCS], or Abnormal Clinically Significant [CS]).
Measured: Day 1 to Day 190
Pulse Rate
Evaluate the clinical significance of test value outside of the reference range.
Measured: Day 1 to Day 190
Respiratory Rate
Evaluate the clinical significance of test value outside of the reference range.
Measured: Day 1 to Day 190
Body Temperature
Evaluate the clinical significance of test value outside of the reference range.
Measured: Day 1 to Day 190
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study startAug 2026 (estimated)
- Primary completionAug 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SchizophreniaStudies of the same condition, open and under way.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bostal Drug Delivery Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742280
- Sponsor's protocol ID
- MW250033
- Status last verified
- Jul 2026
- First submitted
- 15 Jul 2026
- Last updated
- 3 Aug 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label, Multi-Center Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Brexpiprazole for Extended-Release Injection Administered as a Single Dose in Subjects With Schizophrenia
- ClinicalTrials.gov ID
- NCT07742280
- Acronym / sponsor ID
- MW250033
- Conditions
- Schizophrenia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Bostal Drug Delivery Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Aug 2026 (estimated)
- Primary completion
- Aug 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is to evaluate the pharmacokinetics (PK), safety and tolerability of Brexpiprazole, administered subcutaneously, in subjects with schizophrenia.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Brexpiprazole for ER injection, 45 mg | Experimental | Drug: Brexpiprazole for ER injection, 45 mg |
| Brexpiprazole for ER injection, 100 mg | Experimental | Drug: Brexpiprazole for ER injection, 100 mg |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (26 listed)
- Subjects and/or subject's legally acceptable representative (LAR) is able to sign informed consent and subject is willing to comply with the trial protocol and to attend the clinic visits.
- Male or female subjects diagnosed with schizophrenia as per Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) (or later) criteria.
- Subjects with a Clinical Global Impression-Severity of Illness (CGI-S) Score of ≤ 4 at screening and on enrolment prior to IP dosing (Day -1).
- Subjects with Positive and Negative syndrome-scale (PANSS) total score ≤75 at screening and on enrolment prior to IP dosing (Day -1).
- Subjects aged 18-65 years (both inclusive) having Body Mass Index (BMI) between 18.50 to 30.00 kg/m2
Key exclusion criteria (26 listed)
- Subjects with known hypersensitivity to Brexpiprazole or related class of drugs or to any of the excipients of the formulation.
- Subjects currently in acute, manic episodes of schizophrenia, as assessed by the Investigator.
- Subjects with history of or a current DSM-5-TR diagnosis of concurrent mental disorder besides schizophrenia (e.g., schizoaffective-disorder, major depressive disorder, bipolar I disorder, bipolar II disorder, general anxiety disorder, obsessive-compulsive disorder, post-traumatic stress disorder, dementia or mild neurocognitive disorder, and personality disorder).
- Subjects who have any suicidal ideation based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on any of the questions of 'Suicidal Ideation' on the CSSRS for screening. [Refer to Appendix B]
- Subjects with history or presence of neuroleptic malignant syndrome (NMS), tardive dyskinesia, Parkinson's disease, epilepsy or other seizure disorders, cognitive and motor impairment, pathological gambling, dysphagia or other compulsive behaviour
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 |
|---|---|---|
| Brexpiprazole for ER injection, 45 mgSingle-dose, Subcutaneous | Drug | Brexpiprazole for ER injection, 45 mg |
| Brexpiprazole for ER injection, 100 mgSingle-dose, Subcutaneous | Drug | Brexpiprazole for ER injection, 100 mg |
Primary outcome
Cmax
Time frame: Pre-dose to 190 days post-dose
Maximum peak plasma concentration
Clast
Time frame: Pre-dose to 190 days post-dose
Last measurable plasma concentration
Tmax
Time frame: Pre-dose to 190 days post-dose
Time of occurence of Cmax
AUC0-last
Time frame: Pre-dose to 190 days post-dose
Area under curve from time zero to last measurable concentration
Kel
Time frame: Pre-dose to 190 days post-dose
T1/2
Time frame: Pre-dose to 190 days post-dose
Half-life
Vd/F
Time frame: Pre-dose to 190 days post-dose
Volume of distribution
CL/F
Time frame: Pre-dose to 190 days post-dose
Apparent clearance of drug from plasma
MRT
Time frame: Pre-dose to 190 days post-dose
Mean residence time of the drug in the body
AUC_%Extrap_obs
Time frame: Pre-dose to 190 days post-dose
Percentage of AUC due to extrapolation from Tlast to infinity
AEs
Time frame: Day 1 to Day 190
Adverse events
SAEs
Time frame: Day 1 to Day 190
Serious AEs
Change from baseline in physical examination findings
Time frame: Day 1 to Day 190
Change from baseline in clinical physical examination findings will be assessed descriptively for safety monitoring. The assessment includes general appearance, skin, head, ears, eyes, nose and throat, chest and lungs, cardiovascular, abdomen, musculoskeletal and extremities, neurological, psychiatric, and mental status examinations. Individual findings will be evaluated for clinically meaningful changes from baseline.
Blood Pressure
Time frame: Day 1 to Day 190
Evaluate the clinical significance of test value outside of the reference range.
Orthostatic hypotension
Time frame: Day 1 to Day 190
Drop in blood pressure due to a change in body position from standing to supine
Columbia-Suicide Severity Rating Scale (C-SSRS) assessment
Time frame: Day 1 to Day 190
Change in suicidality from baseline.
Clinical Laboratory Tests
Time frame: Day 1 to Day 190
Evaluate the clinical significance of each test value outside of the reference range. Lab tests including blood test for Human immunodeficiency virus (HIV), Hepatitis B virus (HBsAg and HBcAb) and Hepatitis C virus (HCV), haematology (Total WBC count, total RBC count, hemoglobin, HCT (PCV), lymphocytes, monocytes, granulocytes, platelet count, and ANC), biochemistry (Fasting blood glucose, BUN, serum creatinine, creatinine clearance, total bilirubin, SGPT, SGOT, ALP, serum cholesterol, sodium, calcium, potassium, chloride, magnesium, LDL, HDL and TG), serum pregnancy test (only for females of childbearing potential) and urine test
12-lead ECG Assessment
Time frame: Day 1 to Day 190
For safety assessment. ECG findings will be evaluated descriptively based on the overall interpretation (Normal, Abnormal Not Clinically Significant [NCS], or Abnormal Clinically Significant [CS]).
Pulse Rate
Time frame: Day 1 to Day 190
Evaluate the clinical significance of test value outside of the reference range.
Respiratory Rate
Time frame: Day 1 to Day 190
Evaluate the clinical significance of test value outside of the reference range.
Body Temperature
Time frame: Day 1 to Day 190
Evaluate the clinical significance of test value outside of the reference range.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
Related trials for Schizophrenia
RecruitingPhase 3
A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
Schizophrenia, Autism-Related Irritability
Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
Treatment Resistant Disorders
Not yet recruitingObservational study
Sleep Monitoring for Early Detection of Relapse in People With Schizophrenia or Bipolar Disorder Receiving Usual Treatment
Bipolar Disorder (BD), SCHIZOPHRENIA 1 (Disorder)
Not yet recruitingPhase 1
Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
Healthy Adult Participants
Active, not recruiting
Designing and Evaluating a Classroom-Based Mental Health Programme for Adolescents.
Mental Health Promotion
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Brexpiprazole for ER injection, 45 mg and Brexpiprazole for ER injection, 100 mg in people with Schizophrenia, run by Bostal Drug Delivery Co., Ltd.
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 26 inclusion and 26 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: opening soon, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
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?
Cmax (time frame: Pre-dose to 190 days post-dose). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Aug 2026.