A Phase 1, Multicenter, Open-label, Dose-Escalation Trial to Assess the Safety, Tolerability and Pharmacokinetics of Oral Brexpiprazole (OPC- 34712) in Adolescents With Schizophrenia
概览
- 阶段
- 1 期
- 干预措施
- Brexpiprazole (OPC-34712)
- 疾病 / 适应症
- Schizophrenia
- 发起方
- Otsuka Pharmaceutical Development & Commercialization, Inc.
- 入组人数
- 43
- 试验地点
- 10
- 主要终点
- Reported Adverse Events (AEs) at 30 day Follow-Up
- 状态
- 已完成
- 最后更新
- 4天前
概览
简要总结
The purpose of this study is to assess the safety, tolerability and pharmacokinetics (PK) of oral brexpipirazole in adolescent subjects with schizophrenia or Other Related Psychiatric Disorders.
详细描述
Schizophrenia is a severely delibitating mental illness that affects approximately 1% of the world population. The onset of schizophrenia symptoms typically peaks in late adolescence and early adulthood. In a minority of cases, the initial episode may occur during childhood or early adolescence. Patients who experience this "early-onset schizophrenia" exhibit symptoms that are more severe and follow a more chronic course; adolescents with schizophrenia may never achieve full remission of the initial episode. The prognosis for early-onset schizophrenia tends to be poor, and cognitive impairment is greater compared with individuals whose onset of schizophrenia occurs later in life. Several antipsychotics have been investigated for the treatment of adolescent schizophrenia, however, there is a particular challenge because developing bodies are more sensitive to side effects of antipsychotics, particularly with respect to weight gain. In order to enroll a population that includes the younger ages, adolescents with other related psychiatric disorders are also included in this study.
研究者
入排标准
入选标准
- •Male and female subjects 13 to 17 years of age, inclusive, at the time of informed consent.
- •Subjects with a current diagnosis of primary schizophrenia spectrum or bipolar spectrum disorder, as defined by DSM-IV-TR criteria, and confirmed by K-SADS-PL.
- •No psychiatric hospitalizations within the past 12 weeks.
- •Subjects require treatment with antipsychotic medications.
- •Subjects who have received previous outpatient antipsychotic treatment at an adequate dose for an adequate duration (at least 6 weeks) and who showed a previous good response to such antipsychotic treatment (other than clozapine) in the last 12 months.
- •Subjects with a body weight at Screening greater than or equal to 30 kg.
排除标准
- •Sexually active females of childbearing potential and male subjects who are not practicing two different methods of birth control with their partner (or abstinence) during the trial and for 30 days after the last dose of trial medication
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving trial drug.
- •Subjects who have received continuous medication therapy to treat schizophrenia and schizophrenia spectrum diagnosis for less than six months prior to first dose of study medication AND subjects who have received continuous medication therapy to treat bipolar and bipolar spectrum disorder for less than two months in the past three years; or subjects who require more than one antipsychotic..
- •Subjects with a current DSM-IV-TR diagnosis other than schizophrenia spectrum , bipolar spectrum, including any Axis I or Axis II (DSM-IV-TR) disorder.
- •Subjects with a clinical presentation and/or history of any neurodevelopmental disorder
- •Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days.
- •Subjects who currently have clinically significant neurological, hepatic, renal, metabolic, hematological, immunological, cardiovascular, pulmonary, or gastrointestinal disorders such as any history of myocardial infarction, congestive heart failure, HIV seropositive status/acquired immunodeficiency syndrome, or chronic hepatitis B or C.
- •Subjects with IDDM (ie, any subjects using insulin) are excluded. Subjects with non-IDDM may be eligible for the trial if their condition is stable.
- •Subjects with epilepsy or a history of seizures.
- •Any major surgery or blood transfusion within 30 days prior to first dose of trial medication.
研究组 & 干预措施
Cohort 5
4mg, Brexpipraxzole (OPC-34712)
干预措施: Brexpiprazole (OPC-34712)
Cohort 1
0.5 mg, Brexpipraxzole (OPC-34712)
干预措施: Brexpiprazole (OPC-34712)
Cohort 3
2mg, Brexpipraxzole (OPC-34712)
干预措施: Brexpiprazole (OPC-34712)
Cohort 2
1mg, Brexpipraxzole (OPC-34712)
干预措施: Brexpiprazole (OPC-34712)
Cohort 4
3 mg, Brexpipraxzole (OPC-34712)
干预措施: Brexpiprazole (OPC-34712)
结局指标
主要结局
Reported Adverse Events (AEs) at 30 day Follow-Up
时间窗: 30 day Follow-Up
Change from Baseline to Day 17 Hematology
时间窗: Baseline to Day 17
Change from Baseline to Day 17 in Vital Signs
时间窗: Baseline to Day 17
Change from Baseline to Day 14 Physical examination
时间窗: Baseline to Day 14
Change from Baseline to Day 17 Body weight
时间窗: Baseline to Day 17
Change from Baseline to Day 17 Urinalysis
时间窗: Baseline to Day 17
Maximal peak steady-state plasma concentration
时间窗: At Day 14
Change from Baseline to Day 17 Serum chemistry
时间窗: Baseline to Day 17
Including Prolactin concentrations
Time to maximum peak steady-state plasma concentration
时间窗: At Day 14
Area under the concentration-time curve during the dosing interval at steady-state
时间窗: At Day 14
For Brex only, apparent cleanse and apparent volume of distribution
时间窗: At Day 14
Change from Baseline to Day 17 ECGs
时间窗: Baseline to Day 17
Minimum trough steady-state plasma concentration
时间窗: At Day 14
Terminal elimination half-life
时间窗: At Day 14
次要结局
- Mean change in CGI-S score(Day -1 of Dose Titration Phase to Day 7 and Day 14 of Fixed Dose Phase)
- Glycosylated haemoglobin [HbA1c](Baseline to Day 17)
- For subjects with a current diagnosis of bipolar spectrum disorder, mean change in Young Mania Rating Scale (YMRS)(Day -1 to Day 15)
- Change from Baseline to Day 17 Thyroid stimulating hormone [TSH](Baseline to Day 17)
- Change from Baseline to Day 17 Adrenocorticotropic hormone [ACTH](Baseline to Day 17)
- Change from Baseline to Day 17 Cortisol(Baseline to Day 17)
- Change from Baseline to Day 17 Activated partial thromboplastin time [aPTT](Baseline to Day 17)
- Change from Baseline to Day 17 Prothrombin time [PT](Baseline to Day 17)
- Mean change in CGI-I score(Day 7 and Day 14)
- Change from Baseline to Day 17 International normalized ratio [INR](Baseline to Day 17)
- For subjects with a current primary schizophrenia spectrum diagnosis, mean change in Positive and Negative Syndrom Scale (PANSS)(Day-1 to Day 15)