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

Sponsor

Otsuka Pharmaceutical Co., Ltd. (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT05119894

Collaborator

(none)

Enrollment

Arms

Actual Duration (Days)

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Schizophrenia	Drug: Brexpiprazole LAI: Dose 1 Drug: Brexpiprazole LAI: Dose 2 Drug: Brexpiprazole LAI: Dose 3 Drug: Brexpiprazole LAI: Dose 4	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

N/A

Intervention Model:

Sequential Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Actual Study Start Date :

Nov 22, 2021

Actual Primary Completion Date :

Dec 6, 2021

Actual Study Completion Date :

Dec 6, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 64 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

Investigators

Study Director: Takehisa Matsumaru, Otsuka Pharmaceutical Co., Ltd.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT05119894

Other Study ID Numbers:

331-102-00373
jRCT2061210051

First Posted:

Nov 15, 2021

Last Update Posted:

Apr 28, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Schizophrenia

Brexpiprazole

Study Results

No Results Posted as of Apr 28, 2022