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A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
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
2 other identifiers
interventional
N/A
0 countries
N/A
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started Nov 2021
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 12, 2021
CompletedFirst Posted
Study publicly available on registry
November 15, 2021
CompletedStudy Start
First participant enrolled
November 22, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 6, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
December 6, 2021
CompletedApril 28, 2022
April 1, 2022
14 days
November 12, 2021
April 20, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Plasma concentrations of brexpiprazole
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
Study Arms (4)
Brexpiprazole LAI: Dose 1
EXPERIMENTALBrexpiprazole LAI: Dose 2
EXPERIMENTALBrexpiprazole LAI: Dose 3
EXPERIMENTALBrexpiprazole LAI: Dose 4
EXPERIMENTALInterventions
Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1
Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2
Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3
Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Takehisa Matsumaru
Otsuka Pharmaceutical Co., Ltd.
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 12, 2021
First Posted
November 15, 2021
Study Start
November 22, 2021
Primary Completion
December 6, 2021
Study Completion
December 6, 2021
Last Updated
April 28, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will share
- Time Frame
- Data will be available after marketing approval in global markets, or beginning 1-3 years following article Publication. There is no end date to the availability of the data.
- Access Criteria
- Otsuka will share data on an Otsuka-owned remotely accessible data sharing platform with Python and R analytical software. Research requests should be directed to clinicaltransparency@Otsuka-us.com.
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.