(duplicate) Double-Blind Study of VX770 effects on LCI in Cystic Fibro

• Research type

  Research Study

• Full title

  A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Effect of VX-770 on Lung Clearance Index in Subjects with Cystic Fibrosis, the G551D Mutation, and FEV1 >90% Predicted

• IRAS ID

  61443

• Contact name

  Jane Davies

• Sponsor organisation

  Vertex Pharmaceutical Incorporated

• Eudract number

  2010-020546-96

• ISRCTN Number

  n/a

• Research summary

  Vertex Pharmaceuticals Incorporated, is developing an experimental drug called VX-770 as a possible treatment for Cystic fibrosis(CF). The study is being conducted at 8 CF treatment centres in North America, Europe and Canada and will enroll a minimum of 16 subjects aged 6 years and older with CF.After the screening visit, eligible subjects will be randomized 1:1 to receive oral VX-770 or placebo in 1 of 2 treatment sequences.In treatment sequence 1, subjects receive either VX-770 or placebo twice daily for 28 days, then undergo a 28 day Washout, and start treatment sequence 2.In treatment sequence 2 subjects receive either VX-770 or placebo twice daily for 28 days.Subjects will visit the clinic at Days 1, 15 and 29 to undergo visit procedures in each treatment sequence. A follow-up visit is to occur 4 weeks after the last dose of study drug.The subject's participation will last approximately 19 weeks. results from this Phase 2 study will guide the design of future studies of VX-770 in this and younger populations.

• REC name

  London - Harrow Research Ethics Committee

• REC reference

  10/H0715/49

• Date of REC Opinion

  8 Oct 2010

• REC opinion

  Further Information Favourable Opinion