EUCTR2011-004867-65-Outside-EU/EEA进行中（未招募）不适用
Sequential, two-period study to assess the pharmacokinetics, safety & tolerability of single and multiple oral doses of AFQ056 in patients with FXS (Fragile X syndrome) aged 5-11 years (Cohort 1) and 3-4 years (Cohort 2)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 24
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •Genetically confirmed diagnosis of FXS
- •At Screening and first baseline, vital signs, body weight and BMI must be
- •age-specific within normal ranges
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 24
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Use of any other investigational drug within 30 days or 5 half-lives
- •(whichever is longer) of the investigational drug prior to screening until
- •end of study visit.
- •History of hypersensitivity to AFQ056 or any mGluR antagonist.
- •Female patients who are confirmed or suspected to be sexually active.
- •History or presence of any clinically significant disease of any major
- •system organ class, within the past 2 years prior to screening including
- •but not limited to psychiatric, neurological, cardiovascular, endocrine,
- •metabolic, renal, or gastrointestinal disorders (except for typical
- •features of FXS).
- •Loss of =10% of total blood volume within 8 weeks (or less if required
- •for this age group and/or by local regulation) prior to dosing or longer if
- •required for this age group and/or by local regulation.
- •Significant illness that did not completely resolve at least four weeks
- •prior to the first baseline visit.
- •Any abnormal laboratory values at screening or first baseline that are in
- •the opinion of the investigator clinically significant and may jeopardize
- •the safety of the study subject.
- •Use of (or use within at least 5 half lives before dosing) concomitant
- •medications that are strong/moderate inhibitors or inducers of
- •CYP1A1/2, CYP2C9/19 or CYP3A4
- •History or presence of Hepatitis B/C or HIV at screening
研究者
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