A Phase 1b, Open-label Study to Determine the Pharmacokinetics, Safety, and Tolerability of Single, Ascending Doses of Lumateperone Long-acting Injectable Formulations Administered Intramuscularly to Patients With Schizophrenia or Schizoaffective Disorder
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 4
- 主要终点
- Pharmacokinetics: Cmax,oral
研究概览
简要总结
Study ITI-007-037 is a Phase 1b, open-label study to evaluate the safety, tolerability, and PK of lumateperone long-acting injectable (LAI) formulations after a single intramuscular injection in patients with stale schizophrenia or schizoaffective disorder.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Main Inclusion Criteria:
- •Male or female patients between 18 and 55 years of age, inclusive;
- •Clinical diagnosis of schizophrenia or schizoaffective disorder according to Diagnostic and Statistical Manual of Mental Disorders (DSM-5);
- •Clinically stable and free from acute exacerbation of psychosis for at least 3 months prior to Screening;
- •Clinical Global Impression - Severity (CGI-S) score ≤ 3 at Screening and prior to dosing on Day 1;
- •Body mass index (BMI) between 18.0 and 38.0 kg/m2, inclusive at Screening, and a minimum body weight of 50 kg at Screening.
排除标准
- •History of psychiatric condition other than schizophrenia that, in the Investigator's opinion, may be detrimental to participation in the study;
- •Any suicidal ideation or wish to be dead within the past 6 months of Screening, any suicide attempt within the past 2 years prior to Screening, or any current concern for the patient's safety based on the Columbia-Suicide Severity Rating Scale (C-SSRS) (excluding self-injurious, non-suicidal behavior), and/or Investigator assessment that the patient is 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;
- •Has a QT interval corrected for heart rate using Fridericia formula > 450 msec in males or > 470 msec in females, or evidence of clinically significant bundle branch blocks on ECG at Screening.
研究组 & 干预措施
Cohort 5
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 3
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 6
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 4
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 9
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 9
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 8
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 8
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> dose in Part B) of lumateperone LAI formulation (chosen from Part B) after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 3
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X2 after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 7
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 2
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 1
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 6
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 5
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 4
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-X5 after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 1
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E2 after a 5-day washout
干预措施: Lumateperone LAI (Drug)
Cohort 2
Lumateperone 42 mg once daily for 5 days following by a single IM dose of lumateperone 100 mg LAI formulation X500-E3 after a 5-day washout
干预措施: Lumateperone Capsule (Drug)
Cohort 7
Lumateperone 42 mg once daily for 5 days following by a single IM dose (> 100 mg) of lumateperone LAI formulation (chosen from Part A) after a 5-day washout
干预措施: Lumateperone LAI (Drug)
结局指标
主要结局
Pharmacokinetics: Cmax,oral
时间窗: Day 5
Maximum plasma concentration of lumateperone
Pharmacokinetics: Cmax,IM
时间窗: Day 11-60
Maximum plasma concentration of lumateperone
Pharmacokinetics: Tmax,oral
时间窗: Day 5
Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: Tmax,IM
时间窗: Day 11-60
Time of maximum concentration of lumateperone in plasma
Pharmacokinetics: AUC0-t,oral
时间窗: Day 5
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
Pharmacokinetics: AUC0-t,IM
时间窗: Day 11-60
Area under the plasma concentration time curve from time zero to the last measurable of concentration of lumateperone
次要结局
- Change from baseline in alanine aminotransferase(Days 25 and 60)
- Percentage of subjects with treatment-emergent adverse events(up to 30 days after the last protocol-defined study visit)
- Change from baseline in ECG QTcF interval(Days 25 and 60)
- Change from baseline in systolic and diastolic blood pressure(Days 25 and 60)
- Change from baseline in hemoglobin(Days 25 and 60)
- Change from baseline in white blood cell count(Days 25 and 60)
- Change from baseline in aspartate aminotransferase(Days 25 and 60)
- Change from baseline in Abnormal Involuntary Movement Scale (AIMS)(Days 25 and 60)