A Phase 1 interventional study of GLPG2222 single dose and Placebo single dose in Healthy, sponsored by Galapagos NV. Completed at 1 site in Belgium. Open to male participants aged 18 Years to 50 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by Galapagos NV · Phase 1, Interventional, and Treatment
The purpose of this First-in-Human study is to evaluate the safety and tolerability after single ascending oral doses of GLPG2222 given to healthy subjects, compared to placebo (Part 1). Also, the safety and tolerability of multiple ascending oral doses of GLPG2222 given to healthy subjects daily for 14 days compared to placebo, will be evaluated (Part 2).
Furthermore, during the course of the study after single and multiple oral dose administrations, the amount of GLPG2222 present in the blood and urine (pharmacokinetics) will be characterized.
The potential of cytochrome P450 (CYP)3A4 interaction after repeated dosing with GLPG2222 will be explored as well.
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 of GLPG2222 oral suspension
Drug: GLPG2222 single dose
Single dose of placebo oral suspension
Drug: Placebo single dose
Multiple doses of GLPG2222 oral suspension
Drug: GLPG2222 multiple doses
Multiple doses of placebo oral suspension
Drug: Placebo multiple doses
single ascending doses, oral suspension
single doses, oral suspension, matching placebo
multiple ascending doses, daily for 14 days, oral suspension
multiple doses, daily for 14 days, oral suspension, matching placebo
Change versus placebo in number of subjects with adverse events
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of adverse events
Time frame: Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal laboratory parameters
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal laboratory parameters
Time frame: Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal vital signs
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal vital signs
Time frame: Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal electrocardiogram
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal electrocardiogram
Time frame: Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal physical examination
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal physical examination
Time frame: Between screening and 7-10 days after the last dose
Change versus placebo in number of subjects with abnormal pulmonary function
To evaluate the safety and tolerability of GLPG2222 in comparison with placebo after a single oral dose and multiple oral doses in healthy subjects in terms of abnormal pulmonary function as measured by spirometry
Time frame: Between screening and 4 days after the last dose (Part 1 only)
The amount of GLPG2222 in plasma
To characterize the amount of GLPG2222 in plasma over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 48 hours after the (last) dose
The amount of GLPG2222 in urine
To characterize the amount of GLPG2222 in urine over time - pharmacokinetics (PK) - after a single oral dose and multiple oral doses in healthy subjects
Time frame: Between Day 1 predose and 24 hours after the (last) dose
Ratio of 6-b-hydroxycortisol/cortisol in urine
To assess the potential of CYP3A4 interaction after repeated oral dosing with GLPG2222 by means of the ratio of 6-b-hydroxycortisol/cortisol in urine
Time frame: Twelve hours before dosing on Day 1 and Day 14
Plan to share: No
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This study is completed, as verified in Jan 2016. You cannot join it, but the record below documents what was studied.
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Galapagos NV