NCT01325740暂停2 期
A Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of a Single Dose of STX107 in Adults With Fragile X Syndrome
Seaside Therapeutics, Inc.5 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2011年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 暂停
- 发起方
- 入组人数
- 16
- 试验地点
- 5
- 主要终点
- Adverse events will be monitored for tolerability
研究概览
简要总结
The study will consist of a Screening period (up to 14 days), a Treatment period, and a Follow-Up period. Sixteen subjects will be enrolled into two sequential dose cohorts - 10 or 30 mg (or matching placebo) across four study centers.
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 50 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Male subjects 18 to 50 years of age, inclusive.
- •Molecular documentation of the full fragile X mutation.
排除标准
- •Subjects with a history of seizure disorder who are, in the opinion of the Investigator and Medical Monitor, not currently considered to be well controlled.
- •Subjects currently being treated with psychoactive medications (including stimulants and anxiolytics).
- •Subjects with any condition, including alcohol and drug abuse, which might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being.
- •Subjects who plan to initiate or change pharmacologic or non-pharmacologic interventions during the course of the study.
- •Subjects who, in the Investigator's opinion, might not be suitable for the study
研究组 & 干预措施
STX107 10 mg
Active Comparator
干预措施: STX107 (Drug)
Placebo
Placebo Comparator
干预措施: STX107 (Drug)
STX107 30 mg
Active Comparator
干预措施: STX107 (Drug)
结局指标
主要结局
Adverse events will be monitored for tolerability
时间窗: 1 day
physical exam, laboratories, collection of adverse events
次要结局
- Blood levels of STX107 will be measured to define pharmacokinetics(1 day)
研究者
研究点 (5)
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