Flamingo

Details

Therapeutic category
Restore CFTR Function
Trial status
Completed Participating Centres
Phase
Phase II

Full title

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.

The 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
Trial Reference Number
94989
Trial type
Medication
Length of participation
6 - 10 weeks
Intervention
GLPG2222 or Placebo
Recruitment target
50
Last edited date
01/09/2017
CF sponsor
Galapagos NV
CF sponsor type
Commercial

Who can take part?

Age
18+
Top inclusion criteria
  • 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)
Top exclusion criteria
  • Use of CFTR modulator therapy (e.g. lumacaftor or ivacaftor) within 4 weeks prior to the first study drug administration

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