An Open-label Multiple Oral Dose Study to Determine the Safety, Tolerability, and Pharmacokinetics of Lumateperone in Patients, Ages 13 to 17 Years, Diagnosed With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Pharmacokinetics: CL/F
研究概览
简要总结
Study ITI-007-020 is a Phase 1b, multicenter, open-label study to evaluate the safety, tolerability, and PK of lumateperone as treatment for adolescent patients with schizophrenia or schizoaffective disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 13 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients between 13 and 17 years of age, inclusive
- •Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5)
- •Free from acute exacerbation of their psychosis for at least 3 months prior to Screening
- •Clinical Global Impression - Severity (CGI-S) score ≤ 4
- •Body mass index (BMI) within 2 standard deviations of, age- and gender-specific body measurements (based on CDC Clinical Growth Chart, 2000)
- •Ability to swallow capsules
排除标准
- •Has a primary psychiatric diagnosis other than schizophrenia or schizoaffective disorder
- •Reports having experienced suicidal ideation within 6 months prior to Screening, any suicidal behavior within 2 years prior to Screening based on the Columbia-Suicide Severity Rating Scale (C-SSRS), and/or the investigator assesses the patient to be a safety risk to him/herself or others
- •Clinically significant abnormality within 2 years of Screening that in the Investigator's opinion may place the patient at risk or interfere with study outcome variables
- •History of a clinically significant cardiac disorder and/or abnormal screening electrocardiogram (ECG) or a QT interval corrected for heart rate using Fridericia formula > 450 msec in males or > 470 msec in females
研究组 & 干预措施
Lumateperone 42 mg once daily for 5 days
干预措施: Lumateperone 42 mg (Drug)
Lumateperone 28 mg once daily for 5 days
干预措施: Lumateperone 28 mg (Drug)
结局指标
主要结局
Pharmacokinetics: CL/F
时间窗: Day 1 and Day 5
Apparent oral clearance of lumateperone
Pharmacokinetics: Cmax
时间窗: Day 1 and Day 5
Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax
时间窗: Day 1 and Day 5
Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: AUC0-t
时间窗: 0 to 24 hours post-dose on Day 1 and Day 5
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Pharmacokinetics: AUC0-tau
时间窗: 0 to 24 hours post-dose on Day 1 and Day 5
Area under the plasma lumateperone concentration time curve from time zero to the end of dosing (tau)
Pharmacokinetics: t1/2
时间窗: Day 1 and Day 5
Terminal elimination half-life of lumateperone
次要结局
- Change From Baseline in Aspartate Aminotransferase(Baseline and Day 6)
- Change From Baseline in Alanine Aminotransferase(Baseline and Day 6)
- Percentage of Subjects With Treatment-emergent Adverse Events(up to 30 days after last dose, up to a total of 35 days)
- Change From Baseline in Systolic and Diastolic Blood Pressure(Baseline and Day 6)
- Change From Baseline in ECG QT Interval(Baseline and Day 6)
- Change From Baseline in Hemoglobin(Baseline and Day 6)
- Change From Baseline in White Blood Cell Count(Baseline and Day 6)
- Change From Baseline in Abnormal Involuntary Movement Scale (AIMS)(Baseline and Day 6)