A Phase 1 interventional study of GLPG1690 and Itraconazole in Healthy, sponsored by Galapagos NV. Completed at 1 site in United Kingdom. Open to male participants aged 18 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-06-11.
Sponsored by Galapagos NV · Phase 1, Interventional, and Basic science
The sponsor wants to investigate how well the test medicine is taken up by the body when given alongside two other already approved medicines. This kind of study is known as a drug-drug interaction study. In this case the other medicines are itraconazole and voriconazole.
The sponsor will also look at the safety and tolerability of the test medicine when taken alone, and when taken with the approved medicines.
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:
single dose GLPG1690.
Drug: GLPG1690
Single dose itraconazole + single dose GLPG1690.
Drug: GLPG1690 · Drug: Itraconazole
Single dose voriconazole + single dose GLPG1690.
Drug: GLPG1690 · Drug: Voriconazole
A single oral dose of GLPG1690.
A single oral dose of itraconazole.
A single oral dose of voriconazole.
Maximum observed plasma concentration of GLPG1690 (Cmax).
To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.
Time frame: At various time points between Day 1 pre-dose and Day 5
Area under the plasma concentration-time curve from time zero to infinity of GLPG1690 (AUC0-∞).
To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.
Time frame: At various time points between Day 1 pre-dose and Day 5
Apparent terminal half-life of GLPG1690 (t1/2,λz).
To investigate the effect of a single oral dose of itraconazole or voriconazole on the single-dose pharmacokinetics of GLPG1690 in healthy male subjects.
Time frame: At various time points between Day 1 pre-dose and Day 5
Number of incidents of TEAEs.
To assess safety and tolerability of GLPG1690.
Time frame: Between screening and 10 days after the last dose
This study is completed, as verified in Jun 2018. You cannot join it, but the record below documents what was studied.
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Galapagos NV