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)

ovartis Farmacéutica, S.A.0 个研究点目标入组 21 人开始时间: 2012年3月29日最近更新: 2022年4月19日

试验速览

暂无简介。

•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

•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.

发起方

ovartis Farmacéutica, S.A.