A Phase 1, Open-label, Single Ascending Dose, Parallel Arm Trial to Determine the Pharmacokinetics, Safety, and Tolerability of Aripiprazole 2 Month Intramuscular Depot Administered Gluteally in Adult Subjects With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Electrocardiograms (ECGs) [Safety and tolerability]
研究概览
简要总结
This trial will determine the Pharmacokinetics, safety and tolerability of single-dose Aripiprazole administered intramuscularly in adults with schizophrenia
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male and female individuals between 18 and 64 years, inclusive, at screening with a current diagnosis of schizophrenia as defined by Diagnostic and Statistical Manual of Mental Disorders: edition 5 (DSM-5)
- •Body mass index (BMI) between 18 and 35 kg/m^2 at screening
- •Male and female subjects who are surgically sterile, female subjects who have been postmenopausal for at least 12 consecutive months prior to screening or male/female subjects who agree to remain abstinent or practice 2 of the approved birth control methods from screening for at least 150 days after dose of Investigational Medical Product (IMP) for female subjects or 180 days after dose of IMP for male subjects.
- •Documented history of previously tolerating Aripiprazole per investigator's judgment.
排除标准
- •Met DSM-5 criteria for substance use disorder within past 180 days
- •Positive drug screen for drugs of abuse
- •Use of more than 1 antipsychotic medication at screening or baseline, except for oral Aripiprazole administered during tolerability testing and current antipsychotic medication
- •Subjects may not receive varenicline beyond the screening visit.
- •Subjects who had participated in any clinical trial involving a psychotropic medication within 1 month prior to administration of IMP
- •Major surgery within 30 days prior to administration of IMP or surgery during the trial
- •Subjects at significant risk of committing suicide based on history, psychiatric exams
- •Subjects currently in an acute relapse of schizophrenia
- •Subjects with a current DSM-5 diagnosis other than schizophrenia
- •Subjects with a history of neuroleptic malignant syndrome, seizure disorder, or clinically significant tardive dyskinesia
- •Subjects who have had electroconvulsive therapy within 2 months prior to administration of IMP
- •Females who are breast-feeding and/or who have a positive pregnancy test result prior to receiving IMP
- •History of or current hepatitis or Acquired Immunodeficiency Syndrome or carriers of Hepatitis B surface antigen (HBsAG), Hepatitis C antigen (anti-HCV) and/or Human Immunodeficiency Virus (HIV) antibodies
研究组 & 干预措施
Cohort 1
Aripiprazole; single; gluteal
干预措施: Aripiprazole (Drug)
Cohort 2
Aripiprazole; single; gluteal
干预措施: Aripiprazole (Drug)
结局指标
主要结局
Electrocardiograms (ECGs) [Safety and tolerability]
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
Heart rate, RR, PR, WRS and WT intervals will be monitored to assess the safety and tolerability of the drug.
Vital Signs [safety and tolerability]
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
Systolic/diastolic blood pressure, heart rate and body temperature will be monitored to assess the safety and tolerability of the drug.
Suicidality via Columbia-Suicide Severity Rating Scale (C-SSRS) [safety and tolerability]
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
C-SSRS score will be monitored throughout the trial to assess the safety and tolerability of drug
Clinical Laboratory Tests [safety and tolerability]
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
Hematology, clinical chemistry \& urinalysis tests will be performed to assess the safety and tolerability of drug.
Incidence of Adverse Events (AEs) [safety and tolerability]
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
AEs will be monitored to assess safety and tolerability of drug
Extrapyramidal Symptoms (EPS) Rating Scales
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
EPS score will be monitored to assess safety and tolerability of drug
Investigator's Assessment of Injection Site
时间窗: Screening Days -30 to Day 182 post dose/Early Termination
The injection site will be monitored to assess the safety and tolerability of drug
Visual Analog Scale (VAS) Scores for Pain Perception
时间窗: Day 1 to Day 28 post dose
VAS score will be monitored to assess safety and tolerability of drug
次要结局
- Pharmacokinetics - Terminal-phase elimination half-life (t1/2,z)(Day 1 to Day 182/Early Termination)
- Pharmacokinetics - Maximum plasma concentration (Cmax)(Day 1 to Day 182/Early Termination)
- Pharmacokinetics - time of maximum plasma concentration (tmax)(Day 1 to Day 182/Early Termination)
- Pharmacokinetics - area under concentration-time curve (AUC) calculated from time zero to time t (AUCt)(Day 1 to Day 182/Early Termination)
- Pharmacokinetics - AUC calculated from time to infinity(Day 1 to Day 182/Early Termination)