An Open-label, Randomized, Parallel Arm, Bioavailability Trial of Aripiprazole IM Depot Administered in the Deltoid or Gluteal Muscle in Adult Subjects With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
研究概览
简要总结
The purpose of this study is to determine whether aripiprazole injection into the shoulder or the buttocks produces similar effects in the body
详细描述
Extended-release gluteal intramuscular (IM) injection of aripiprazole has been tested in subjects with schizophrenia for safety and tolerability. This study will compare the gluteal IM aripiprazole injection with deltoid IM aripiprazole injection for safety and tolerability.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 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
- •Diagnosis of schizophrenia
- •Stabilized on oral antipsychotic medication
- •Good physical health
- •BMI 18 to 35 kg/m2
- •Prior history of tolerating aripiprazole
排除标准
- •Sexually active males who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 180 days following the last dose of trial medication, or have not had an orchidectomy or sexually active females of childbearing potential who will not commit to utilizing 2 of the approved birth control methods or who will not remain abstinent during the trial and for 150 days following the last dose of trial medication. Abstinence will be permitted if it is confirmed and documented at every trial visit. If employing birth control, 2 of the following precautions must be used: vasectomy, tubal ligation, vaginal diaphragm, intrauterine device, birth control pill, birth control depot injections, implant, condom or sponge with spermicide.
- •Subjects who have met DSM-IV-TR criteria for substance abuse or dependence within the past 180 days; including alcohol and benzodiazepines, but excluding caffeine and nicotine.
- •Subjects with a positive drug screen for cocaine or other drugs of abuse (excluding stimulants and other prescribed medications and marijuana).
- •Use of any psychotropic medications other than their current antipsychotic medication.
- •Use of any CYP2D6 and CYP3A4 inhibitors, or CYP3A4 inducers within 14 days (fluoxetine 28 days) prior to dosing and for the duration of the trial.
- •Females who are pregnant or lactating.
- •Subjects who had participated in a previous IM depot trial within the last one year; or who had previously enrolled and received trial medication in an aripiprazole IM depot clinical trial.
- •Any major surgery within 30 days prior to enrollment.
- •Evidence of organ dysfunction or any clinically significant deviation from normal in physical, electrocardiographic, or clinical laboratory examinations.
- •Subjects who have a significant risk of committing suicide based on history, routine psychiatric status examination, investigator's judgment, or who have an answer of "yes" on questions 4 or 5 (current or over the last 30 days) on the Baseline/Screening version of the Columbia Suicide Severity Rating Scale (C-SSRS).
- •Subjects currently in an acute relapse of schizophrenia.
- •Subjects with a current DSM-IV-TR diagnosis other than schizophrenia, including schizoaffective disorder, major depressive disorder, bipolar disorder, delirium, dementia, amnestic or other cognitive disorders. Also, subjects with borderline, paranoid, histrionic, schizotypal, schizoid or antisocial personality disorder.
- •Subjects who were considered treatment-resistant to antipsychotic medication.
- •Subjects who have had electroconvulsive therapy within 2 months of administration of trial drug.
- •Subjects with a history of neuroleptic malignant syndrome or clinically significant tardive dyskinesia as assessed by the investigator.
- •Any other sound medical reason not to be entered into the trial, as determined by the clinical investigator.
- •Subjects who are known to be allergic, intolerant, or unresponsive to prior treatment with aripiprazole or other quinolinones.
研究组 & 干预措施
Deltoid
Deltoid injection site
干预措施: Aripiprazole IM Depot (Drug)
Gluteal
Gluteal injection site
干预措施: Aripiprazole IM Depot (Drug)
结局指标
主要结局
Maximum Observed Plasma Concentration (Cmax) of Dehydro-Aripiprazole
时间窗: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Maximum Observed Plasma Concentration (Cmax) of Aripriprazole
时间窗: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole intramuscular (IM) depot injected in the deltoid muscle compared to the gluteal muscle based on aripiprazole maximum (peak) plasma concentrations (Cmax) PK parameter.
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Aripiprazole
时间窗: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28, and AUC from time zero to infinity PK parameters.
Area Under the Concentration-Time Curve Infinity (AUC Infinity); Area Under the Concentration-Time Curve 28 (AUC 28), and Area Under the Concentration-Time Curve t (AUC t): Dehydro-Aripiprazole
时间窗: Day 1: 4 hr, 8 hr, and 12 hr post dose, Days 2, 3, 5, 7, 9, 11, 13, 15, 17, 19, 21, 25, 28, 35, 42, 49, 56, 63, 70, 77, 84, 98, 112 and 126/Early termination
Relative bioavailability (Frel) of aripiprazole IM depot injected in the deltoid muscle compared to the gluteal muscle based on area under the concentration-time curve (AUC) from time zero to the time of last measurable concentration (AUCt), AUC time curve 28 and AUC from time zero to infinity PK parameters.
次要结局
- Number of Participants With Vital Signs of Potential Clinical Relevance-Temperature(Day 1, Day 14, Day 28 and Day 126/Early termination)
- Number of Participants With Vital Signs of Potential Clinical Relevance-Heart Rate(Day 1, Day 14, Day 28 and Day 126/Early termination)
- Number of Participants With Categorical Scores on the Columbia Suicide Severity Rating Scale.(Screening, Baseline, Week 1, Week 2, Week 8, Week 18 visit and Last visit.)
- Number of Participants Reporting Treatment Emergent Adverse Events (TEAE).(Starting at the time the ICF was signed to Day 126/Early termination)
- Number of Participants With Laboratory Values of Potential Clinical Relevance.(Day 1, Day 28, Day 126/Early termination)
- Number of Participants With Vital Signs of Potential Clinical Relevance-Blood Pressure(Day 1, Day 14, Day 28 and Day 126/Early termination)
- Number of Participants With Electrocardiogram (ECG) Measurements of Potential Clinical Relevance(Day 1, Day 14, Day 28 and Day 126/Early termination)
- Visual Analog Scale (VAS) Score at Day 1, Day 14, Day 28 and Last Visit.(Day 1, Day 14, Day 28 and last visit)