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

April 20, 2022 updated by: Otsuka Pharmaceutical Co., Ltd.

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Study Type

Interventional

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Brexpiprazole LAI: Dose 1
Drug: Brexpiprazole LAI: Dose 1
Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1
Experimental: Brexpiprazole LAI: Dose 2
Drug: Brexpiprazole LAI: Dose 2
Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2
Experimental: Brexpiprazole LAI: Dose 3
Drug: Brexpiprazole LAI: Dose 3
Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3
Experimental: Brexpiprazole LAI: Dose 4
Drug: Brexpiprazole LAI: Dose 4
Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 22, 2021

Primary Completion (Actual)

December 6, 2021

Study Completion (Actual)

December 6, 2021

Study Registration Dates

First Submitted

November 12, 2021

First Submitted That Met QC Criteria

November 12, 2021

First Posted (Actual)

November 15, 2021

Study Record Updates

Last Update Posted (Actual)

April 28, 2022

Last Update Submitted That Met QC Criteria

April 20, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 331-102-00373
  • jRCT2061210051 (Other Identifier: jRCT)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD 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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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