A Phase 2 interventional study of GLPG1837 dose 1 and GLPG1837 dose 2 in Cystic Fibrosis, sponsored by Galapagos NV. Completed at 16 sites in 5 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-12-07.
Sponsored by Galapagos NV · Phase 2, Interventional, and Treatment
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.
1,581 studies on the registry are indexed under Cystic Fibrosis; 190 are open to participants now.
This study's enrollment of 26 is below the median of 36 across 1,034 interventional studies indexed under Cystic Fibrosis.
Browse Cystic Fibrosis studies →Galapagos NV is the lead sponsor of 103 studies on the registry; none are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 11 (79%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
GLPG1837 twice daily oral dosing - morning and evening, for 4 weeks
Drug: GLPG1837 dose 1 · Drug: GLPG1837 dose 2 · Drug: GLPG1837 dose 3
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for one week
two GLPG1837 tablets in the morning and two GLPG1837 tablets in the evening, for two weeks
Changes in adverse events
To evaluate the safety and tolerability of GLPG1837 in terms of adverse events at every visit
Time frame: Up to 9 weeks
Changes in laboratory parameters
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal laboratory parameters at every visit
Time frame: Up to 7 weeks
Changes in vital signs - composite outcome measure
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal vital signs as measured by temperature, blood pressure, heart rate and respiratory rate, at every visit
Time frame: Up to 9 weeks
Changes in physical examination - composite outcome measure
To evaluate the safety and tolerability of GLPG1837 in terms of abnormalities during physical examination at every visit
Time frame: Up to 9 weeks
Changes in electrocardiogram
To evaluate the safety and tolerability of GLPG1837 in terms of abnormal electrocardiogram at every visit
Time frame: Up to 7 weeks
Changes in sweat chloride concentration
To evaluate the effect of GLPG1837 in terms of change in sweat chloride concentration, a biomarker to measure cystic fibrosis transmembrane conductance regulator (CFTR) ion channel function at every visit
Time frame: Up to 9 weeks
Changes in pulmonary function (forced expiratory volume in 1 second, FEV1) assessed by spirometry
To explore the effect of GLPG1837 in terms of change in pulmonary function (forced expiratory volume in 1 second, FEV1) assessed by spirometry at every visit
Time frame: Up to 9 weeks
Plasma levels of GLPG1837: Cmax, the maximum observed plasma concentration
To characterize the pharmacokinetics (PK) of GLPG1837 by measuring the amount in plasma between Day 8 and Day 29 at every visit; On Day 29, an 8-hour profile will determine the Cmax, the maximum observed plasma concentration
Time frame: Up to 3 weeks
Plasma levels of GLPG1837: tmax, the time of occurrence of Cmax
To characterize the pharmacokinetics (PK) of GLPG1837 by measuring the amount in plasma between Day 8 and Day 29 at every visit; On Day 29, an 8-hour profile will determine the tmax, the time of occurrence of Cmax
Time frame: Up to 3 weeks
Plasma levels of GLPG1837: AUC, the area under the plasma concentration-time curve
To characterize the pharmacokinetics (PK) of GLPG1837 by measuring the amount in plasma between Day 8 and Day 29 at every visit; On Day 29, an 8-hour profile will determine the AUC, the area under the plasma concentration-time curve
Time frame: Up to 3 weeks
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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Galapagos NV