A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
Primary Purpose
Schizophrenia
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Brexpiprazole LAI: Dose 1
Brexpiprazole LAI: Dose 2
Brexpiprazole LAI: Dose 3
Brexpiprazole LAI: Dose 4
Sponsored by
About this trial
This is an interventional treatment trial for Schizophrenia
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
Brexpiprazole LAI: Dose 1
Brexpiprazole LAI: Dose 2
Brexpiprazole LAI: Dose 3
Brexpiprazole LAI: Dose 4
Arm Description
Outcomes
Primary Outcome Measures
Plasma concentrations of brexpiprazole
Secondary Outcome Measures
Full Information
NCT ID
NCT05119894
First Posted
November 12, 2021
Last Updated
April 20, 2022
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05119894
Brief Title
A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision:Change the Development plan
Study Start Date
November 22, 2021 (Actual)
Primary Completion Date
December 6, 2021 (Actual)
Study Completion Date
December 6, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Brexpiprazole LAI: Dose 1
Arm Type
Experimental
Arm Title
Brexpiprazole LAI: Dose 2
Arm Type
Experimental
Arm Title
Brexpiprazole LAI: Dose 3
Arm Type
Experimental
Arm Title
Brexpiprazole LAI: Dose 4
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole LAI: Dose 1
Intervention Description
Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole LAI: Dose 2
Intervention Description
Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole LAI: Dose 3
Intervention Description
Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3
Intervention Type
Drug
Intervention Name(s)
Brexpiprazole LAI: Dose 4
Intervention Description
Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4
Primary Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Takehisa Matsumaru
Organizational Affiliation
Otsuka Pharmaceutical Co., Ltd.
Official's Role
Study Director
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing 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.
IPD Sharing 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.
Learn more about this trial
A Clinical Pharmacology Trial of Brexpiprazole Long Acting Injectable (LAI) Administered as a Single Dose in Patients With Schizophrenia
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