NCT01474278已完成1 期
A Multi-centre, Randomized, Double-blind, Placebo-controlled, Two-period Cross-over, Exploratory Biomarker and Safety and Tolerability Study of a Single Dose of RO5028442 in Adult Male High-functioning Autistic Patients
适应症
干预措施
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 19
- 主要终点
- Efficacy: Behavior assessments
研究概览
简要总结
This multi-center, randomized, double-blind study will evaluate exploratory biomarkers and the safety and tolerability of a single dose of RO5028442 in adult male high-functioning autistic patients. In a cross-over design, patients will be randomized to receive either a single dose of RO5028442 or matching placebo with a washout period of 7-14 days. Anticipated time on study is up to approximately 9 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Patients with a diagnosis of Autistic Disorder as defined by DSM-IV, confirmed by the team and supported with the Autistic Diagnostic Observation Schedule (ADOS)
- •Male adults, 18 to 45 years of age
- •IQ > 70 (Wechsler Adult Intelligence Scale-Full scale)
- •Body mass index (BMI) 18 to 35 kg/m2 inclusive
- •Aberrant Behavior Checklist (ABC) - Irritability subscale score </= 13
排除标准
- •Positive urine test for drugs of abuse
- •Alcohol and/or substance abuse/dependence during the last 12 months
- •Positive for hepatitis B, hepatitis C or HIV infection
- •Clinically relevant cardiovascular, renal, hepatic or hematologic disease or disorder
- •Active inflammatory pulmonary disease
- •History of epilepsy/seizure disorder (except for simple febrile seizures)
- •Initiation of new or major change in psychosocial intervention within 4 weeks prior to randomization
- •Treatment with any investigational agent within 90 days prior to screening
- •History of hypersensitivity or allergic reactions
研究组 & 干预措施
1
Experimental
干预措施: RO5028442 (Drug)
2
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Efficacy: Behavior assessments
时间窗: up to 24 hours post-dose
Safety: Incidence of adverse events
时间窗: up to 24 hours post-dose
次要结局
未报告次要终点
研究者
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