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

Schizophrenia Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05119894
• Other study ID #: 331-102-00373
• Secondary ID: jRCT2061210051
• Status: Withdrawn
• Phase: Phase 1
• Start date: November 22, 2021
• Est. completion date: December 6, 2021

Study information

• Verified date: April 2022
• Source: Otsuka Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 6, 2021
• Est. primary completion date: December 6, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 64 Years

Eligibility

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.

Related Conditions & MeSH terms

• Schizophrenia

Intervention

Drug:
• Brexpiprazole LAI: Dose 1
Cohort 1: Single Dose Intramuscular Injection: Brexpiprazole LAI Dose 1
• Brexpiprazole LAI: Dose 2
Cohort 2: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 2
• Brexpiprazole LAI: Dose 3
Cohort 3: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 3
• Brexpiprazole LAI: Dose 4
Cohort 4: Single Dose Intramuscular Injection:Brexpiprazole LAI Dose 4

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Otsuka Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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