A Phase 1, Randomized, Double-blind, Placebo-controlled, Multiple-dose Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of ALKS 9072 in Subjects With Chronic Stable Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- Maximum concentration in plasma following last dose
研究概览
简要总结
This study will determine the pharmacokinetics (PK), safety, and tolerability of ALKS 9072 (also known as ALKS 9070) after 4 monthly doses in adults with chronic stable schizophrenia.
详细描述
Three active treatment groups and a placebo group are planned. Randomization will be sequential by dose level across the sites with placebo assignments randomly inserted. Each subject's participation will be approximately 8 months, including screening, treatment period, and a 3-month follow-up period.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Diagnosis of chronic schizophrenia that is clinically stable
- •Body mass index (BMI) between 18.5 and 35.0 kg/m2, inclusive
- •Stable antipsychotic medication regimen for >/= 2 months before Screening
- •Be willing and able to be confined to an inpatient clinical research unit for a total of 37 days during the course of the study
排除标准
- •Aripiprazole used within 30 days before Screening
- •History of intolerance of or allergy or hypersensitivity to aripiprazole, its excipients, other antipsychotic agents, or INTRALIPID (including peanuts, soy, egg, or glycerol)
- •Current diagnosis of an Axis I disorder other than schizophrenia
- •History of seizure disorder or any condition associated with seizures
- •History of neuroleptic malignant syndrome (NMS)
- •Positive test result for HIV, hepatitis B surface antigen, or anti-hepatitis C antibodies
- •Received medication by IM injection within 30 days before Screening
- •Monoamine oxidase inhibitors (eg, phenelzine, tranylcypromine, selegiline) used within 30 days before Screening
- •DSM-IV-TR diagnosis of alcohol or substance dependence, with the exception of nicotine or caffeine dependence within 12 months before Screening
- •Donation of blood or blood components within 4 weeks before Screening
研究组 & 干预措施
ALKS 9072, High dose
干预措施: ALKS 9072, High dose (Drug)
ALKS 9072, Low dose
干预措施: ALKS 9072, Low dose (Drug)
ALKS 9072, Med dose
干预措施: ALKS 9072, Med dose (Drug)
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Maximum concentration in plasma following last dose
时间窗: 4 months
Area under the plasma concentration time curve over the last dosing interval
时间窗: 4 months
Time to maximum concentration in plasma following last dose
时间窗: 4 months
次要结局
- Number of Participants with Adverse Events(4 months)