A Multiple Dose Study of Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of ABT-288 in Stable Subjects With Schizophrenia
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 81
- 主要终点
- Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
研究概览
简要总结
Evaluate the safety, tolerability and pharmacokinetics of ABT-288 in order to determine the maximum tolerated dose of ABT-288 in 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
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has signed informed consent;
- •Current DSM-IV-TR diagnosis of schizophrenia;
- •Clinically stable on the same single second-generation antipsychotic for the past 8 weeks;
- •Meets study-specific PANSS criteria;
- •Willing and able to cooperate with cognitive testing
- •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
- •Subject has a substance dependence disorder that has not been in sustained remission for at least 1 year;
- •Diagnosis of schizoaffective disorder;
- •Bipolar disorder, manic episode, dementia, OCD, or drug-induced psychosis or current major depressive disorder;
- •Diagnoses with mental retardation; acute psychosis hospitalization within past 6 months;
- •Current clozapine treatment; suicidal ideation or behavior;
- •BMI of 39 or greater; current homicidal or violent ideation;
- •Medical or CNS condition other than schizophrenia that could affect cognitive performance or testing; relevant drug sensitivity or allergy; positive urine screen for alcohol or drugs of abuse;
- •Positive hepatitis or HIV test result;
- •Recent clinically significant illness/infection or surgery;
- •Recent blood product transfusion, donation or loss of 5 mL/kg of blood;
- •Visual, hearing or communication disability
研究组 & 干预措施
4
ABT288 vs placebo administered orally once daily for 14 days
干预措施: Placebo (Drug)
1
ABT-288 vs placebo capsules administered orally once daily for 14 days
干预措施: Placebo (Drug)
2
ABT-288 vs placebo capsules administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
1
ABT-288 vs placebo capsules administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
2
ABT-288 vs placebo capsules administered orally once daily for 14 days
干预措施: Placebo (Drug)
3
ABT-288 vs placebo capsules administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
3
ABT-288 vs placebo capsules administered orally once daily for 14 days
干预措施: Placebo (Drug)
4
ABT288 vs placebo administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
5
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
5
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: Placebo (Drug)
6
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
6
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: Placebo (Drug)
7
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
7
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: Placebo (Drug)
8
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
8
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: Placebo (Drug)
9
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: ABT-288 (Drug)
9
ABT-288 vs placebo administered orally once daily for 14 days
干预措施: Placebo (Drug)
结局指标
主要结局
Physical Exams, Brief Neurological Exams, Vitals, Orthostatic Vitals, ECG, Laboratory tests,
时间窗: Days -1 to 21
Pharmacokinetics; optional CSF for arms 7, 8 & 9
时间窗: Days -1 to 21
次要结局
- Pharmacodynamics: Pittsburgh Sleep Quality Index-Modified(Day -1, Day 15)
- Columbia Suicide Severity Rating Scale(Screening, Day 15)
- Extrapyramidal Symptom Rating Scale(Day -1, Day 14)
- Pharmacodynamics: CANTAB & PANSS(Screening, Day -1, Day 14)