NCT02019329已完成1 期
A SINGLE-CENTER, RANDOMIZED, INVESTIGATOR/SUBJECT-BLIND, MULTIPLE-DOSE, PLACEBO-CONTROLLED, PARALLEL STUDY TO INVESTIGATE THE SAFETY, TOLERABILITY AND PHARMACOKINETICS OF RO5545965 IN PATIENTS WITH SCHIZOPHRENIA ON RISPERIDONE.
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 主要终点
- Incidence of adverse events
研究概览
简要总结
This randomized, double-blinded, placebo-controlled study will investigate the safety, tolerability, and pharmacokinetics of multiple doses of RO5545965 administered orally to psychiatrically stable patients with schizophrenia receiving risperidone.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males or females aged >/= 18 years and </= 60 years
- •Clinically stable, mild or moderate schizophrenia
- •On stable antipsychotic treatment for the last 6 months
- •Generally healthy in the investigator's opinion, based on assessment of medical history, physical examination, vital signs, electrocardiogram (ECG), and the results of the hematology, clinical chemistry, urinalysis, serology, and other laboratory tests
- •Willingness to be hospitalized for approximately 3 weeks
- •BMI > 18.5 kg/m2 and < 38 kg/m2
- •Use of highly effective contraception as defined by the study protocol. Men must also not donate sperm until at least 30 days after the last dose, and women cannot be pregnant or breastfeeding
排除标准
- •Treatment with antiparkinson medication including anticholinergic drugs
- •Treatment with depot antipsychotic medication within the last three months prior to screening
- •Participation in a clinical trial with an investigational drug or device < 3 months prior to screening
- •Smokes more than 20 cigarettes per day
- •Current drug abuse (excluding nicotine) or drug abuse within 3 months prior to the screening visit
- •Any donation of blood or significant blood loss within three months prior to first administration of the study drug
- •Use of prohibited medications (including vitamins or herbal remedies) taken within 14 days or within 5 times the elimination half-life of the medication (whichever is longer) before the first study drug administration
研究组 & 干预措施
Placebo + risperidone
Placebo Comparator
干预措施: Placebo (Other)
Placebo + risperidone
Placebo Comparator
干预措施: risperidone (Drug)
RO5545965 + risperidone
Experimental
干预措施: RO5545965 (Drug)
RO5545965 + risperidone
Experimental
干预措施: risperidone (Drug)
结局指标
主要结局
Incidence of adverse events
时间窗: Up to 10 weeks
Health of the patients, assessed through a complete medical examination including physical examination, electrocardiogram (ECG) and vital signs.
时间窗: Up to 10 weeks
次要结局
- Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of RO5545965(17 days)
- Pharmacokinetics: Plasma area under the concentration-time curve (AUC) of risperidone(15 days)
研究者
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