SchizophreniaPhase 1NCT05119894

A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

A Phase 1 study testing Brexpiprazole LAI: Dose 1, Brexpiprazole LAI: Dose 2 and Brexpiprazole LAI: Dose 3 in people with Schizophrenia, run by Otsuka Pharmaceutical Co., Ltd..

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record

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Trial summary

The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia. Read more about this study

Who is it for?: Ages 18 to 64 years
Conditions the study is for: Schizophrenia
What is being tested?: Brexpiprazole LAI: Dose 1, Brexpiprazole LAI: Dose 2 and Brexpiprazole LAI: Dose 3
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 0 participants
Where: No sites listed yet
Study dates: 22 Nov 2021to 6 Dec 2021
Phase: Phase 1
Are there results?: None posted in the registry

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

Japanese patients who are between 18 and 64 years of age, inclusive, at the time of informed consent
Patients with a diagnosis of schizophrenia as defined by the DSM-5® criteria
Patients who are able to remain at the trial site for the protocol-defined hospitalization period
Patients with a body mass index [BMI = body weight (kg) / height (m)2] of no less than 18.5 kg/m2 and less than 35.0 kg/m2 at screening
Patients who are able to provide written informed consent (if the patient is a minor or is hospitalized for medical protection, his or her legally acceptable representative must also give informed consent) prior to commencement of any trial procedure and are judged by the investigator or subinvestigator to be able to meet all protocol-defined requirements

Who cannot join

Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (eg, 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) as defined by the DSM-5® criteria. However, this exclusion does not apply to caffeine- or tobacco-related disorders.
Patients who fail to meet the mandatory washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of the drugs or foods during the trial period
Patients who have received electroconvulsive therapy (ECT) within 60 days prior to the administration of IMP
Patients with clinically significant nervous, hepatic, renal, metabolic, blood, immune, cardiovascular, respiratory, or digestive system disorders However, such patients may be enrolled if the condition is mild or well controlled and is considered to not affect safety or PK evaluations.
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 prior to the administration of IMP
Patients with a positive drug test at screening (according to the results from the central laboratory). However, such patients may be enrolled if their condition is not diagnosed as a substance-related or addictive disorder, according to the DSM-5® diagnostic criteria.

About this study

Official title: A Multicenter, Open-label, Clinical Pharmacology Trial to Determine the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia

The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia.

Conditions: Schizophrenia
Being tested: Brexpiprazole LAI: Dose 1, Brexpiprazole LAI: Dose 2, Brexpiprazole LAI: Dose 3, Brexpiprazole LAI: Dose 4
Medical subject headings: Schizophrenia

What participants receive

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

Brexpiprazole LAI: Dose 1Drug
Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1
Brexpiprazole LAI: Dose 2Drug
Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2
Brexpiprazole LAI: Dose 3Drug
Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3
Brexpiprazole LAI: Dose 4Drug
Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4

Study groups in NCT05119894
Study group	Role	What they receive
Brexpiprazole LAI: Dose 1	Experimental	Not described Receives: Drug: Brexpiprazole LAI: Dose 1
Brexpiprazole LAI: Dose 2	Experimental	Not described Receives: Drug: Brexpiprazole LAI: Dose 2
Brexpiprazole LAI: Dose 3	Experimental	Not described Receives: Drug: Brexpiprazole LAI: Dose 3
Brexpiprazole LAI: Dose 4	Experimental	Not described Receives: Drug: Brexpiprazole LAI: Dose 4

What is being measured

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

Plasma concentrations of brexpiprazole
Measured: Blood Sampling for plasma drug measurement Day 1 (predose and 4, 8, 12 hours postdose), 2, 3, 5,7,9,11,13,15,17,19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 112, 126, 154, 182

Timeline

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

22 Nov 20216 Dec 2021

First posted15 Nov 2021
Study start22 Nov 2021
Primary completion6 Dec 2021
Study completion6 Dec 2021

Why it stopped: Sponsor decision:Change the Development plan

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.
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: Not applicable
Intervention model: Sequential
Masking: None (open label)
Enrolment: 0 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05119894
Sponsor's protocol ID: 331-102-00373
Other IDs: jRCT2061210051
Status last verified: Apr 2022
First submitted: 12 Nov 2021
Last updated: 28 Apr 2022
Results posted: No
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?

Official record

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
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Deep Brain Stimulation for Treatment-Resistant Schizophrenia
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Pharmacokinetics and Relative Bioavailability of Intranasal vs Intramuscular Olanzapine in Healthy Adult Participants
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All Schizophrenia trials

Study at a glance

From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Open-label, Clinical Pharmacology Trial to Determine the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT05119894
Acronym / sponsor ID: 331-102-00373
Conditions: Schizophrenia
Phase: Phase 1
Study type: Interventional
Recruitment status: WithdrawnReason stopped: Sponsor decision:Change the Development plan
Enrolment: 0 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 22 Nov 2021 (actual)
Primary completion: 6 Dec 2021 (actual)
Study completion: 6 Dec 2021 (actual)
First posted: 15 Nov 2021 (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.

The purpose of this study is to determine the pharmacokinetics (PK), tolerability and safety of brexpiprazole LAI following a single administration in subjects with schizophrenia.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Sequential
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Brexpiprazole LAI: Dose 1	Experimental	Drug: Brexpiprazole LAI: Dose 1
Brexpiprazole LAI: Dose 2	Experimental	Drug: Brexpiprazole LAI: Dose 2
Brexpiprazole LAI: Dose 3	Experimental	Drug: Brexpiprazole LAI: Dose 3
Brexpiprazole LAI: Dose 4	Experimental	Drug: Brexpiprazole LAI: Dose 4

Who may qualify

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

Key inclusion criteria (5 listed)

Japanese patients who are between 18 and 64 years of age, inclusive, at the time of informed consent
Patients with a diagnosis of schizophrenia as defined by the DSM-5® criteria
Patients who are able to remain at the trial site for the protocol-defined hospitalization period
Patients with a body mass index [BMI = body weight (kg) / height (m)2] of no less than 18.5 kg/m2 and less than 35.0 kg/m2 at screening
Patients who are able to provide written informed consent (if the patient is a minor or is hospitalized for medical protection, his or her legally acceptable representative must also give informed consent) prior to commencement of any trial procedure and are judged by the investigator or subinvestigator to be able to meet all protocol-defined requirements

Key exclusion criteria (6 listed)

Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (eg, 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) as defined by the DSM-5® criteria. However, this exclusion does not apply to caffeine- or tobacco-related disorders.
Patients who fail to meet the mandatory washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of the drugs or foods during the trial period
Patients who have received electroconvulsive therapy (ECT) within 60 days prior to the administration of IMP
Patients with clinically significant nervous, hepatic, renal, metabolic, blood, immune, cardiovascular, respiratory, or digestive system disorders However, such patients may be enrolled if the condition is mild or well controlled and is considered to not affect safety or PK evaluations.
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 prior to the administration of IMP

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 LAI: Dose 1Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1	Drug	Brexpiprazole LAI: Dose 1
Brexpiprazole LAI: Dose 2Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2	Drug	Brexpiprazole LAI: Dose 2
Brexpiprazole LAI: Dose 3Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3	Drug	Brexpiprazole LAI: Dose 3
Brexpiprazole LAI: Dose 4Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4	Drug	Brexpiprazole LAI: Dose 4

Primary outcome

Plasma concentrations of brexpiprazole
Time frame: Blood Sampling for plasma drug measurement Day 1 (predose and 4, 8, 12 hours postdose), 2, 3, 5,7,9,11,13,15,17,19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 112, 126, 154, 182

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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.

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.
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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.

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Brexpiprazole LAI: Dose 1, Brexpiprazole LAI: Dose 2 and Brexpiprazole LAI: Dose 3 in people with Schizophrenia, run by Otsuka Pharmaceutical 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 5 inclusion and 6 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: withdrawn, as of the sponsor's last update on 28 Apr 2022. 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 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?

The study was withdrawn before enrolling participants, so there are no results.

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?

Plasma concentrations of brexpiprazole (time frame: Blood Sampling for plasma drug measurement Day 1 (predose and 4, 8, 12 hours postdose), 2, 3, 5,7,9,11,13,15,17,19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 91, 98, 112, 126, 154, 182). 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 NCT05119894.

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 28 Apr 2022.