SchizophreniaPhase 1NCT04118127

A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses

A Phase 1 study testing 2mg conventional tablet, once-weekly tablets 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 evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients 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?: 2mg conventional tablet, once-weekly tablets
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 73 participants
Where: 1 siteJapan
Study dates: 17 Oct 2019to 3 Mar 2021
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 the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2
Patients with a body mass index [BMI = body weight (kg)/height (m)2] of 18.5 or higher and lower than 35.0 at screening
Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial
Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration"

Who cannot join

Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (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, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders)
Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period
Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
Patients who are using clozapine at the time of informed consent
Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration
Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)

Trial locations and contacts

1 site in 1 country.

Japan1 site

Sankeikai Nishigahara Hospital
Tokyo

Other trials in Japan

About this study

Official title: A Multi-center, Open-label Clinical Pharmacology Trial to Investigate the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses in Patients With Schizophrenia

To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

Read the detailed description

A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses.

The trial comprises the single-dose period (Cohort 1) and the multiple-dose period (Cohort 2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma drug concentrations obtained in the single-dose period (Cohort 1).

Conditions: Schizophrenia
Being tested: 2mg conventional tablet, once-weekly tablets
Keywords: Schizophrenia,brexpiprazole,open-label,linical pharmacology
Medical subject headings: Schizophrenia

What participants receive

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

2mg conventional tablet, once-weekly tabletsDrug
In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.

Study groups in NCT04118127
Study group	Role	What they receive
2mg conventional tablet, once-weekly tablets	Experimental	Not described Receives: Drug: 2mg conventional tablet, once-weekly tablets

What is being measured

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

Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1
To evaluate Cmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .
Measured: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose
Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1
To evaluate Tmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .
Measured: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose
Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2
To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.
Measured: prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose
Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2
To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.
Measured: prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose

Timeline

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

17 Oct 20193 Mar 2021

First posted8 Oct 2019
Study start17 Oct 2019
Primary completion16 Feb 2021
Study completion3 Mar 2021

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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 73 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04118127
Sponsor's protocol ID: 331-102-00150
Status last verified: Feb 2024
First submitted: 4 Oct 2019
Last updated: 5 Aug 2024
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 5 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multi-center, Open-label Clinical Pharmacology Trial to Investigate the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses in Patients With Schizophrenia
ClinicalTrials.gov ID: NCT04118127
Acronym / sponsor ID: 331-102-00150
Conditions: Schizophrenia
Keywords: Schizophrenia,brexpiprazole,open-label,linical pharmacology
Phase: Phase 1
Study type: Interventional
Recruitment status: Completed
Enrolment: 73 participants (actual)
Lead sponsor: Otsuka Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 17 Oct 2019 (actual)
Primary completion: 16 Feb 2021 (actual)
Study completion: 3 Mar 2021 (actual)
First posted: 8 Oct 2019 (actual)
Results: Posted 5 Aug 2024

Clinical summary

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

To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

Detailed description

A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
2mg conventional tablet, once-weekly tablets	Experimental	Drug: 2mg conventional tablet, once-weekly tablets

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 the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2
Patients with a body mass index [BMI = body weight (kg)/height (m)2] of 18.5 or higher and lower than 35.0 at screening
Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial
Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration"

Key exclusion criteria (6 listed)

Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (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, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders)
Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period
Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
Patients who are using clozapine at the time of informed consent
Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration

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
2mg conventional tablet, once-weekly tabletsIn each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.	Drug	2mg conventional tablet, once-weekly tablets

Primary outcome

Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1
Time frame: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose
To evaluate Cmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .
Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1
Time frame: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose
To evaluate Tmax of OPC-34712 following single oral administration of the QW formulation (24 mg and 48 mg) and 2 mg conventional tablet .
Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2
Time frame: prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose
To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.
Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2
Time frame: prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose
To evaluate Tmax of OPC-34712 following multiple oral administration of the QW formulation 48 mg.

Results and safety

Results posted to the registry on 5 Aug 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Cohort 2	35	32
Cohort 1	38	22

Primary outcome: Maximum Plasma Concentration (Cmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1

Time frame: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	Conventional Tablet 2mg n = 33	QW Formuration 24mg n = 33	QW Formuration 48mg n = 22
Value	25.37 (10.46)	98.62 (46.76)	222.3 (114.3)

Primary outcome: Time to Maximum (Peak) Plasma Concentration (Tmax) of OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1

Time frame: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose. Median (Full Range). Unit: hour

Measure	Conventional Tablet 2mg n = 33	QW Formuration 24mg n = 33	QW Formuration 48mg n = 22
Value	4.00 (1.75 to 24.37)	25.37 (8.75 to 49.50)	25.00 (8.60 to 46.42)

Primary outcome: Cmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2

Time frame: prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose. Mean (Standard Deviation). Unit: ng/mL

Measure	QW Formuration 48mg n = 32
Value	225.0 (147.7)

Primary outcome: Tmax of OPC-34712 Following Multiple Oral Administrations of 48 mg QW Formulation in Cohort 2 Period 2

Time frame: prepose, 3, 9, 24, 36, 48, 72, 120, 168, 240, 312 hours postdose. Median (Full Range). Unit: hour

Measure	QW Formuration 48mg n = 32
Value	24.61 (8.50 to 49.25)

Adverse events

Time frame: From the start of IMP administration throughout follow-up period Cohort 1: up to 93 days (Period 1: up to 28 days, Period 2: up to 35 days, Period 3: up to 30 days) Cohort 2: up to 88 days (Period 1: up to 28 days, Period 2: up to 60 days). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Cohort 1 Period 2	0 of 34 (0%)	21 of 34 (61.8%)	0 of 34
Cohort 1 Period 3	1 of 23 (4.3%)	11 of 23 (47.8%)	0 of 23
Cohort 2 Period 2	0 of 34 (0%)	20 of 34 (58.8%)	0 of 34
Cohort 1 Period 1	0 of 38 (0%)	16 of 38 (42.1%)	0 of 38
Cohort 2 Period 1	0 of 35 (0%)	16 of 35 (45.7%)	0 of 35

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2024.
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.

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
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Not yet recruiting
Deep Brain Stimulation for Treatment-Resistant Schizophrenia
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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 2mg conventional tablet, once-weekly tablets 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 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: finished, as of the sponsor's last update on 5 Aug 2024. 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 5 Aug 2024). 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 OPC-34712 Following Single Oral Administration of 24 mg and 48 mg QW Formulation or 2 mg Conventional Tablet in Cohrt1 (time frame: prepose, 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose). The study lists 4 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 NCT04118127.

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 5 Aug 2024.