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Trial record 3 of 197 for:    Recruiting, Not yet recruiting, Available Studies | Pharmacology

A Clinical Pharmacology Trial of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses

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ClinicalTrials.gov Identifier: NCT04118127
Recruitment Status : Recruiting
First Posted : October 8, 2019
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Brief Summary:
To evaluate the pharmacokinetics (PK), tolerability, and safety of brexpiprazole QW formulation administered as single and multiple doses in patients with schizophrenia.

Condition or disease Intervention/treatment Phase
Schizophrenia Drug: 2mg conventional tablet, once-weekly tablets Phase 1

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 the single-dose period (Cohort 1) and the multiple-dose period (Cohort 2). The dose used in the multiple-dose period (Cohort 2) will be determined based on plasma drug concentrations obtained in the single-dose period (Cohort 1).


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multi-center, Open-label Clinical Pharmacology Trial to Investigate the Pharmacokinetics, Tolerability, and Safety of Brexpiprazole Once-weekly (QW) Formulation Administered as Single and Multiple Oral Doses in Patients With Schizophrenia
Estimated Study Start Date : October 2019
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Schizophrenia

Arm Intervention/treatment
Experimental: 2mg conventional tablet, once-weekly tablets Drug: 2mg conventional tablet, once-weekly tablets
In each cohort, subjects will receive a brexpiprazole 2 mg conventional tablet on Day 1of Period 1, the QW formulation on Day 1 of Period 2 and 3, as single and multiple dose in a fasted state.




Primary Outcome Measures :
  1. Plasma concentrations of brexpiprazole [ Time Frame: Blood Sampling for plasma drug measurement predose and 2,4, 6, 8, 12, 24, 48, 72, 120, 168, 240, 312 hours postdose ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with a diagnosis of schizophrenia based on the Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5)
  2. 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
  3. 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
  4. 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
  5. 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 Criteria:

  1. 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)
  2. 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
  3. Patients who have previously undergone gastrointestinal surgery that could affect pharmacokinetic evaluations
  4. Patients who are using clozapine at the time of informed consent
  5. Patients who have received electro-convulsive therapy within 60 days before commencement of IMP administration
  6. 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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04118127


Contacts
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Contact: Drug Information Center +81-3-6361-7314

Locations
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Japan
Sankeikai Nishigahara Hospital Recruiting
Tokyo, Japan
Sponsors and Collaborators
Otsuka Pharmaceutical Co., Ltd.
Investigators
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Study Director: Osamu Sato Otsuka Pharmaceutical Co., Ltd.

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Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT04118127     History of Changes
Other Study ID Numbers: 331-102-00150
First Posted: October 8, 2019    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Otsuka Pharmaceutical Co., Ltd.:
Schizophrenia,brexpiprazole,open-label,linical pharmacology
Additional relevant MeSH terms:
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Schizophrenia
Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders
Brexpiprazole
Serotonin Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Dopamine Agonists
Dopamine Agents