A Phase 3, 2 Part, Randomized, Double-Blind, Placebo Controlled, Parallel Group Study to Evaluate the Pharmacokinetics, Efficacy and Safety of VX 770 in Subjects Aged 6 to 11 Years with Cystic Fibrosis and the G551D Mutation - ENVISIO

Vertex Pharmaceuticals Incorporated0 个研究点目标入组 40 人开始时间: 2009年6月26日最近更新: 2012年10月22日

适应症

试验速览

暂无简介。

•- Male or female with confirmed diagnosis of CF
•- Must have the G551D-CFTR mutation in at least 1 allele (any known or unknown mutations allowed in second allele).
•- FEV1 40% to 105% (inclusive)
•- 6 to 11 years of age (inclusive)
•- Weight 15 kg without shoes at Screening
•- Females of child-bearing potential must have a negative serum pregnancy test at Screening
•- Subjects of child-bearing potential and who are sexually active must meet the contraception requirements
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 52
•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

•- History of any illness or condition that, in the opinion of the investigator might confound the results of the study or pose an additional risk in administering study drug to the subject
•- An acute upper or lower respiratory infection, pulmonary exacerbation, or changes in therapy for pulmonary disease within 4 weeks before Day 1 (first dose of study drug).
•- Abnormal liver function
•- Abnormal renal function
•- History of solid organ or hematological transplantation
•- History of alcohol, medication or illicit drug abuse within one year prior to Day 1 (first dose of study drug)
•- Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within 30 days prior to Screening.
•- Use of inhaled hypertonic saline treatment. (Subjects who have stopped inhaled hypertonic saline treatment will be eligible to participate, but they must have undergone a wash-out period of 4 weeks prior to Day 1 [first dose of study drug])
•- Concomitant use of any inhibitors or inducers of CYP 3A4

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