Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)
Status:
Completed
Trial end date:
2016-11-01
Target enrollment:
Participant gender:
Summary
32 cystic fibrosis patients with the G551D mutation will be treated for 4 weeks, consisting
of three consecutive treatment periods: two 1-week periods followed by one 2-week period,
evaluating one dose of GLPG1837 each. After the treatment period, there is a 7-10 days
follow-up period.
During the course of the study, subjects will be examined for any side effects that may occur
(safety and tolerability).
Changes in sweat chloride will be assessed as biomarker from baseline onwards, and changes in
pulmonary function (efficacy) will be explored throughout the study. The amount of GLPG1837
present in the blood (pharmacokinetics) will also be determined.