A sequential, open-label, two-period study to assess the pharmacokinetics, safety and tolerability of two dose levels of AFQ056 in male, adolescent patients with Fragile X Syndrome (12 to 18 years inclusive)

ovartis Pharma Services AG0 个研究点目标入组 12 人开始时间: 2011年10月31日最近更新: 2012年3月19日

适应症

试验速览

暂无简介。

•1. Male patients with FXS aged 12 - 18 years.
•2. Confirmed diagnosis of FXS by sequencing (>200 CGG repeats in the fmr1 gene)
•3. Absence of cardiovascular, gastrointestinal, renal, orthopedic, neurological or nervous system co-morbidities (excluding FXS symptoms)
•4. Body weight and body mass index must be within 10th to 90th percentile of the age-specific range
•Other protocol-defined inclusion criteria may apply
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 12
•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

•1. Any subject who does not fulfill each of the inclusion criteria
•2. Smokers (reported tobacco use within the last 3 months prior to screening and/or urine cotinine =500 ng/mL
•3. Significant illness within 2 weeks prior to the screening visit.
•4. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism or excretion of drugs
•5. Any use of CYP3A4 inhibitors or inducers within 4 weeks prior to dosing
•6. Use of any herbal supplement or over the counter drugs within 4 weeks prior to dosing.
•7. Positive HIV or hepatisis B/C
•8. History of drug or alcohol abuse within 12 months prior to dosing
•Other protocol-defined exclusion criteria may apply

发起方