Status:
COMPLETED
A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses
Lead Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Schizophrenia
Eligibility:
All Genders
18-64 years
Phase:
PHASE1
Brief Summary
To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.
Detailed Description
A multi-center, open-label clinical pharmacology trial to investigate the PK, tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses. The trial comprises t...
Eligibility Criteria
Inclusion
- Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
- Patients capable of staying at the trial site from the day before investigational medicinal product (IMP) administration to the 8th day following IMP administration in both Period 1 and Period 2
- Patients with a body mass index \[BMI = body weight (kg)/height (m)2\] of 18.5 or higher and lower than 35.0 at screening
- Persons who provide written informed consent before commencement of any trial-related procedures and whom the investigator or subinvestigator judges to be capable of following all the conditions of this trial
- Patients who, in the judgement of the investigator or subinvestigator, have stable psychotic symptoms maintained by administration of an antipsychotic (other than clozapine) within the dosing range indicated separately, before commencement of investigational medicinal product (IMP) administration"
Exclusion
- Patients with a diagnosis of a concurrent mental disorder besides schizophrenia (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, personality disorder, etc) based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) (However, this exclusion does not apply to caffeine- or tobacco-related disorders)
- Patients who fail to meet the specified requisite washout periods for the prohibited concomitant drugs and foods before commencement of IMP administration, or patients who are anticipated to take any of these drugs or foods during the study period
- Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
- Patients who are using clozapine at the time of informed consent
- Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration
- Patients with clinically problematic disorders of the nervous system, liver, kidneys, metabolic system, blood, immune system, cardiovascular system, lungs, or digestive system (However, such patients may be included if the condition is mild or well-controlled and is considered to not affect safety or pharmacokinetic evaluations.)
Key Trial Info
Start Date :
October 17 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 3 2021
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT04118127
Start Date
October 17 2019
End Date
March 3 2021
Last Update
August 5 2024
Active Locations (1)
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1
Sankeikai Nishigahara Hospital
Tokyo, Japan