NCT02707562

Study of GLPG1837 in Subjects With Cystic Fibrosis (G551D Mutation)

A Phase IIa, Open-label Study of Multiple Doses of GLPG1837 in Subjects With Cystic Fibrosis and the G551D Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 26 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Cystic Fibrosis

Interventions

Type	Name	Description
DRUG	GLPG1837 dose 1	two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
DRUG	GLPG1837 dose 2	two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
DRUG	GLPG1837 dose 3	two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks

Timeline

• Start date: 2016-02-01
• Primary completion: 2016-11-01
• Completion: 2016-11-01
• First posted: 2016-03-14
• Last updated: 2016-12-07

Locations

16 sites across 5 countries: Australia, Czechia, Germany, Ireland, United Kingdom