Flamingo
Details
- Therapeutic approach
- Restore CFTR Function
- Trial status
- Closed with results Participating Centres
- Trials Tracker ID
- TT001766
- Last updated
- 01/09/2017
A Phase IIa, randomized, double-blind, placebo-controlled study to evaluate multiple doses of GLPG2222 in subjects with Cystic Fibrosis who are homozygous for the F508del mutation.
Study detailsThe purpose of this study is to find out whether GLPG2222, taken by mouth as tablet once a day, is safe, well-tolerated and effective in improving your signs and symptoms of cystic fibrosis. The study will also evaluate how the body takes in and breaks down the study drug (GLPG2222). The amount of drug in your blood will be measured at specific study visits after you start taking the drug. These measurements will show how quickly the drug is taken up by the body, how quickly it is broken down, when it reaches a steady level in the blood, and how long it stays in the body
- Phase
- Phase 2
- Length of participation
- 6 - 10 weeks
- Recruitment target
- 50
- CF sponsor
- Galapagos NV
- CF sponsor type
- Commercial
Who can take part?
- Age range
- 18 years and older
- Including people
Age 18 years or older
Homozygous for the F508del CFTR mutation
Weight >=40kg during screening period
FEV1 > = 40% of predicted normal for age, gender and height at screening (pre- or postbronchodilator)- Excluding people
Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration
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