NCT02690519

Study of GLPG1837 in Subjects With Cystic Fibrosis (S1251N Mutation)

A Phase IIa, Open-label Study of Two Doses of GLPG1837 in Subjects With Cystic Fibrosis and the S1251N Mutation

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 7 (actual)
• Sponsor: Galapagos NV · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

At least 6 cystic fibrosis patients with the S1251N mutation will be treated for 4 weeks, consisting of two consecutive treatment periods of two weeks 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	one GLPG1837 tablet in the morning and one GLPG1837 tablet in the evening, for 2 weeks
DRUG	GLPG1837 dose 2	one GLPG1837 tablet in the morning and one GLPG1837 tablet in the evening, for 2 weeks

Timeline

• Start date: 2016-01-01
• Primary completion: 2016-08-01
• Completion: 2016-09-01
• First posted: 2016-02-24
• Last updated: 2016-10-11

Locations

5 sites across 2 countries: Belgium, Netherlands