NCT01043458已完成1 期
A Single Dose Study of the Safety, Tolerability, and Pharmacokinetics of ABT-126 in Stable Subjects With Schizophrenia
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Adverse Events
研究概览
简要总结
A study to investigate the process by which ABT-126 is absorbed, distributed, metabolized and eliminated by the body of stable schizophrenic volunteers receiving treatment with an atypical antipsychotic.
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
- Double (Participant, Investigator)
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
- •Subject has signed informed consent;
- •Current diagnosis of schizophrenia;
- •Clinically stable on the same single second-generation (atypical) antipsychotic for the past 8 weeks;
- •Meets study-specific criteria for Positive and Negative Syndrome Scale (PANSS);
- •Females are not pregnant, not breast-feeding;
- •Females are post-menopausal or surgically sterile or practicing birth control;
- •Males are surgically sterile or agree to be sexually inactive or use barrier method of birth control
排除标准
- •Diagnosis of schizoaffective disorder;
- •Diagnosis with mental retardation;
- •Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- •Acute psychosis hospitalization within past 6 months;
- •Bipolar disorder, manic episode, dementia, obsessive-compulsive disorder, or drug-induced psychosis or current major depressive disorder;
- •Current clozapine treatment;
- •Suicidal ideation or behavior;
- •BMI of 39 or greater;
- •Relevant drug sensitivity or allergy;
- •Positive hepatitis or HIV test result; positive urine screen for drugs of abuse or alcohol;
- •Recent clinically significant illness/infection or surgery;
- •Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
研究组 & 干预措施
1
Experimental
ABT-126 Low Dose
干预措施: ABT-126 (Drug)
2
Experimental
ABT-126 High Dose
干预措施: ABT-126 (Drug)
3
Experimental
Placebo for ABT-126
干预措施: Placebo for ABT-126 (Drug)
结局指标
主要结局
Adverse Events
时间窗: Duration of study
ABT-126 levels in blood (plasma)
时间窗: Pre-dose to 144 hours post-dose
Clinical laboratory tests, vital signs and electrocardiogram (ECG)
时间窗: Pre-dose to 72 hours post-dose
次要结局
未报告次要终点
研究者
研究点 (2)
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